SUPPORT RESOURCES FOR YOU

Hello, thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today we’ll talk about why AJOVY should be considered as a first choice for patients new to preventive migraine therapy for whom an injectable treatment is appropriate.

My name is Dr Wade Cooper and I’m a board-certified neurologist and clinical associate professor of neurology and anesthesiology at the University of Michigan.

You’ve likely had this experience: your patient has chronic or episodic migraine and you conclude that it is time to move them to a preventive therapy. You now have to choose a treatment.

Why should you start with AJOVY?

We will answer this question by looking at a few topics. First we’ll go over How is AJOVY different, we’ll review the clinical profile of AJOVY, then its safety profile, and we’ll conclude with administration and dosing information.

Let’s get into it then, shall we?

AJOVY is indicated for the preventive treatment of migraine in adults. As we continue, please note that AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

How is AJOVY different?

Let’s start with its antibody type. AJOVY is a fully humanized IgG2Δa monoclonal antibody. It was specifically bioengineered to reduce unwanted activation of the immune system.

Bhakta et al studied the selectivity of the molecule and found that AJOVY only binds to what it’s supposed to target—that is, the CGRP ligand—and not to other related calcitonin family members.

It’s helpful when first starting your patients on a preventive migraine therapy to know that AJOVY behaves as it was intended to. It’s also helpful to know that AJOVY was made in a way that avoids triggering your patients’ immune system.

As we move on to look at the clinical profile of AJOVY, it’s important to note that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

To be confident of AJOVY as the right choice for your patients and to assure ourselves of the reliability of the clinical data we’re about to explore, let’s briefly review the study designs of the HALO and Long-Term Extension studies that investigated AJOVY.

AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials.

Patients were randomized in either AJOVY Monthly dosing, AJOVY Quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, run-in period, followed by a 12-week intervention period, with a final evaluation at Week 12.

Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial.

Please note that the long-term extension study was not placebo controlled, but patients were blinded as to the dosing regimen.

Now that we’ve gone over the study designs, let’s dive into the clinical results…

…that established sustained efficacy with no evidence of “wearing off” for AJOVY. Today, we’ll specifically look at patients with chronic migraine. If you’d like to review the results for episodic migraine, please visit AJOVYhcp.com.

The primary endpoint investigated in the HALO chronic migraine trial was the mean change from baseline in the monthly average number of headache days of at least moderate severity for both monthly and quarterly dosing options during the 12-week period.

In the HALO Chronic Migraine study, AJOVY monthly dosing demonstrated a statistically significant improvement, with a mean reduction from baseline of 5.1 headache days at month 3 versus 3.3 days for placebo as we see here. In the long-term extension study, the mean reduction was 6.8 headache days with monthly dosing. Comparable results were seen in patients with episodic migraine in both the HALO and Long-Term Extension study.

Let us now take it a step further and review the published post hoc analyses that investigated “wearing off” for selected dosing periods of AJOVY.

To assess AJOVY over these selected dosing periods, data for patients with chronic and episodic migraine from the HALO trials who rolled over into the Long-Term Extension study were included in the post hoc analyses. Let’s again focus in on patients with chronic migraine.

The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into two: weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Let’s look at the figures for the weekly average number of migraine days during weeks 1 through 3. And now let’s compare them with the number of migraine days during week 4. As the chart indicates, the weekly number of migraine days was similar between the beginning and end of the dosing period, across all the months shown. Note, for all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.

As we’ve just seen, there is no evidence of “wearing off” for AJOVY from one dose to the next. You can give your patients the chance to experience lasting protection against migraine with AJOVY. Is this not the reason for putting them on a preventive therapy? It’s something to ask yourself.

Alongside efficacy, we know when starting a patient on preventive migraine therapy that safety is often top of mind. Here we’ll look at the safety profile of AJOVY to ensure that you know what to expect when making the change.

Shown here are the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo from the HALO trials.

Furthermore, less than 1% of patients experienced constipation, and less than 1% of patients experienced hypertension compared to less than 1% for placebo.

How does this information compare to what you’re seeing in your clinical experience? It’s something to keep in mind.

Now looking at the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients.

What’s worth noting is that no new safety signals were identified in the Long-Term Extension study.

Another interesting fact about AJOVY is that it’s not metabolized by cytochrome P450 enzymes,…

…therefore interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Having looked at the safety profile of AJOVY, let’s look at some administration and dosing information that may help your patients in their transition to a preventive therapy.

AJOVY is available in an autoinjector. And, as a matter of fact, 97% of HCP and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies.

It has a button-free, push-down mechanism and it locks after use. It’s also not made with natural rubber latex.

When taking AJOVY, there’s no loading dose, no dose titration, and it can be administered at home or in office.

Patients have an option to take AJOVY either monthly or quarterly. Having such options may lend itself to your patients, especially if their circumstances better allow for one dosing option over the other. It’s a decision that you and your patients can make together at the appropriate time.

We hope the information provided here helps you in deciding to start your patients new to preventive migraine therapy on AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Living with migraine is a burden we understand, so we hope your patients get the care they need. For more information on AJOVY, please visit AJOVYhcp.com, where you can consult the full Prescribing Information. Thank you for taking the time to watch our video presentation.

Hello. Thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today I’d like to discuss with you: what does sustained efficacy mean with AJOVY?

My name is Dr Jessica Ailani and I’m a board-certified neurologist with a sub-specialty in headache as well as a professor of clinical neurology at Medstar Georgetown University Hospital.

I’m sure you’ve experienced something similar to the following scenario: a patient is referred to you because their migraine is not well controlled with their treatment plan, and so you decide that a change is needed. Which preventive therapy would you prescribe next?

Let’s take a look at why AJOVY may be an appropriate option for your patients. We’ll cover how AJOVY is different and review its clinical profile.

AJOVY is indicated for the preventive treatment of migraine in adults. It is also contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

So—How is AJOVY different?

AJOVY is a fully humanized IgG2Δa monoclonal antibody.

It also has a long half-life of 31 days. Once steady state is reached, elimination of AJOVY is similar for monthly and quarterly dosing, which is approximately 5 to 6 half-lives.

Furthermore, the binding of AJOVY is selective. AJOVY was found to attach to what it’s supposed to target—that is, the CGRP ligand—and not to other related calcitonin family members. It’s helpful when starting your patients on a preventive therapy to know that AJOVY selectively targets the CGRP ligand and nothing more.

As we move on to review the clinical profile, keep in mind that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Let us now take a look at the clinical profile that established…

…sustained efficacy with no evidence of “wearing off” for AJOVY, starting with data from the HALO and Long-Term Extension studies. Afterwards we will review the FOCUS trial and see how its findings may also be relevant to your clinical practice in treating patients who aren’t seeing a sufficient improvement with their migraine.

AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials.

Patients were randomized to either AJOVY Monthly dosing, AJOVY Quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, run-in period, followed by a 12-week intervention period, with a final evaluation at Week 12.

Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial.

Please note that the long-term extension study was not placebo-controlled, but patients were blinded as to the dosing regimen.

The primary endpoint investigated during this 12-week period in the HALO chronic migraine trial was the mean change from baseline in the monthly average number of headache days of at least moderate severity for both monthly and quarterly dosing options.

Please note that in today's presentation, we'll only be looking at data from the chronic migraine trial. If you'd like to review the results for episodic migraine, please visit AJOVYhcp.com.

In the HALO Chronic Migraine study, AJOVY monthly dosing demonstrated a statistically significant improvement, with a mean reduction from baseline of 5.1 headache days at month 3 versus 3.3 days for placebo, as we see here. In the long-term extension study, the mean reduction was 6.8 headache days with monthly dosing. Similar results were seen in patients with quarterly dosing.

Let’s now take a look at the post hoc analyses that investigated “wearing off” for selected dosing periods of AJOVY.

These selected dosing periods were assessed by looking at data for patients from the HALO trials who rolled over into the Long-Term Extension study. Once again, let’s focus on patients with chronic migraine.

The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Here are the numbers for the weekly average number of migraine days during weeks 1 through 3. And now compared to the number of migraine days during the end of the dosing period, or week 4. As we can see, the weekly number of migraine days was similar between weeks 1 through 3 and week 4, and that was true across all the months shown. Note, for all post hoc analyses, no determination of statistical significance can be made and no conclusions should be drawn.

We therefore see that there is no evidence of “wearing off” for AJOVY from one dose to the next. Have you observed any such trends in your clinical practice? With AJOVY, you can give your patients the chance to experience lasting protection against migraine.

Please be reminded that the most common adverse reactions in clinical trials (at least 5% and greater than placebo) were injection site reactions.

The adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo in the HALO trials are shown here.

And in the Long-Term Extension study, the adverse reactions that occurred in more than 6% of patients were as shown above.

Another study that may be relevant to your clinical practice is the FOCUS trial. FOCUS was a phase 3b, 12-week, multicenter, randomized, double-blind, placebo-controlled study. It evaluated chronic and episodic migraine patients, on monthly or quarterly doses of AJOVY, who experienced an inadequate response to 2 or more classes of prior preventive treatments. The most common reason for inadequate response was poor efficacy in all arms of the study.

The primary endpoint looked at the mean change from baseline in the monthly average number of migraine days during the 12-week period.

Here are the results: patients who received the monthly dose of AJOVY experienced 4.1 fewer monthly migraine days on average versus 0.6 days with placebo. Patients on the quarterly dose experienced similar results.

Furthermore, during the 12-week period, 34% of patients on a monthly dose of AJOVY saw a 50% reduction or more in their mean monthly number of migraine days versus 9% on placebo. Similar results were seen in patients on the quarterly dose of AJOVY.

These findings suggest that AJOVY may be appropriate for your migraine patients who, based on your clinical experience, you believe may not be getting results that are adequate. It’s something to consider when choosing a preventive therapy for your patients.

We’ve finished reviewing the FOCUS study with the safety data you see here. These were the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo.

With all the information we presented here today, we hope you find the right migraine therapy for your patients who are experiencing an inadequate efficacy response from their current treatment. Living with migraine is a great challenge too many people face, and so we hope your patients get the results they seek. To give them a chance to have more migraine-free days, prescribe AJOVY—the long-acting, anti-CGRP injection with lasting protection against migraine. You can learn more about AJOVY at AJOVYhcp.com, where you can consult the full Prescribing Information and more. Thank you very much for watching.

Hello, thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today we’ll talk about understanding the safety profile of AJOVY.

I’m Dr Sara Sacco and I’m the Director at the Carolinas Headache Clinic in Charlotte, North Carolina.

I’m sure you’ll agree that the safety profile of preventive migraine therapy is just as important as efficacy and considerations could include concomitant medications, over-active immune responses, constipation, hypertension, and or latex allergies in your decision-making process. As we begin this presentation, I’d like you to keep these considerations in mind when assessing AJOVY.

Today, we’ll review the safety profile of AJOVY as well as its efficacy and administration options so you can make an informed decision when prescribing.

You’ll recall AJOVY is indicated for the preventive treatment of migraine in adults. Please note AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

I’d like to start with how AJOVY was designed. It was specifically bioengineered to reduce unwanted activation of the immune system which is achieved by its antibody type. AJOVY is a fully humanized IgG2Δa monoclonal antibody that selectively targets the CGRP ligand and no other related calcitonin family members. This is particularly helpful when deciding on preventive therapy, especially for patients needing to limit unnecessary immune activity.

AJOVY is also not metabolized by cytochrome P450 enzymes. Therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Before we go any further, it’s important to understand the core clinical trials that established our safety data, so you can be confident when making treatment decisions. Let’s review the study designs for the HALO and Long-term Extension studies. AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized to either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a run-in period, followed by a 12-week intervention period, with a final evaluation at Week 12. Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.

Let’s move on to the safety results of the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of the patients on AJOVY and greater than placebo. What’s notable here when keeping the side effects of preventive therapies top of mind is that less than 1% of patients experienced constipation or hypertension with AJOVY compared to less than 1% for placebo. And ≤2% of patients discontinued due to adverse events in both the AJOVY and placebo treatment arms.

In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. I’d like to add that no new safety signals were identified in the Long-Term Extension study.

Please note, hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Now that we have established the safety profile of AJOVY, let me briefly remind you of the efficacy results so that you have the full picture. As a general note, we will only be discussing episodic migraine results. If you’d like to review the results of the chronic migraine trial, please visit AJOVYhcp.com.

The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period.

As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated

Hello, thank you for joining us to learn more about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine. Today we’ll talk about understanding the safety profile of AJOVY.

I’m Dr Sara Sacco and I’m the Director at the Carolinas Headache Clinic in Charlotte, North Carolina.

I’m sure you’ll agree that the safety profile of preventive migraine therapy is just as important as efficacy and considerations could include concomitant medications, over-active immune responses, constipation, hypertension, and or latex allergies in your decision-making process. As we begin this presentation, I’d like you to keep these considerations in mind when assessing AJOVY.

Today, we’ll review the safety profile of AJOVY as well as its efficacy and administration options so you can make an informed decision when prescribing.

You’ll recall AJOVY is indicated for the preventive treatment of migraine in adults. Please note AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

I’d like to start with how AJOVY was designed. It was specifically bioengineered to reduce unwanted activation of the immune system which is achieved by its antibody type. AJOVY is a fully humanized IgG2Δa monoclonal antibody that selectively targets the CGRP ligand and no other related calcitonin family members. This is particularly helpful when deciding on preventive therapy, especially for patients needing to limit unnecessary immune activity.

AJOVY is also not metabolized by cytochrome P450 enzymes. Therefore, interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Before we go any further, it’s important to understand the core clinical trials that established our safety data, so you can be confident when making treatment decisions. Let’s review the study designs for the HALO and Long-term Extension studies. AJOVY was studied in HALO—two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized to either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a run-in period, followed by a 12-week intervention period, with a final evaluation at Week 12. Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.

Let’s move on to the safety results of the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of the patients on AJOVY and greater than placebo. What’s notable here when keeping the side effects of preventive therapies top of mind is that less than 1% of patients experienced constipation or hypertension with AJOVY compared to less than 1% for placebo. And ≤2% of patients discontinued due to adverse events in both the AJOVY and placebo treatment arms.

In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. I’d like to add that no new safety signals were identified in the Long-Term Extension study.

Please note, hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Now that we have established the safety profile of AJOVY, let me briefly remind you of the efficacy results so that you have the full picture. As a general note, we will only be discussing episodic migraine results. If you’d like to review the results of the chronic migraine trial, please visit AJOVYhcp.com.

The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period.

As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated a mean reduction of 5.1 migraine days with monthly dosing. Comparable results were also seen for quarterly dosing.

We’ve discussed the safety and efficacy of AJOVY. Let’s now move beyond the medicine itself to another important aspect of injectable therapy—the administration process. AJOVY is available in an autoinjector. And, 97% of healthcare professional and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies.

It has a button-free, push-down mechanism. For safety, the device locks after use with no visible needle. It’s also made without any natural rubber latex, which is helpful for patients who may be allergic. With AJOVY, there’s no loading dose, no dose titration, and it can be administered at home or in the office.

Let’s bring this back to your practice. Earlier I mentioned certain considerations you might make when evaluating patients for preventive migraine therapy. In summary, AJOVY may be an appropriate treatment option because it has an established safety profile, it’s not metabolized by cytochrome P450 enzymes, delivers sustained efficacy, and is available in an easy-to-use Autoinjector.

We hope you found this information helpful and consider AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine for your patients. To learn more about AJOVY or review the full Prescribing Information, please visit AJOVYhcp.com.

a mean reduction of 5.1 migraine days with monthly dosing. Comparable results were also seen for quarterly dosing.

We’ve discussed the safety and efficacy of AJOVY. Let’s now move beyond the medicine itself to another important aspect of injectable therapy—the administration process. AJOVY is available in an autoinjector. And, 97% of healthcare professional and patient evaluators found the AJOVY Autoinjector easy to use in two Human Factor studies.

It has a button-free, push-down mechanism. For safety, the device locks after use with no visible needle. It’s also made without any natural rubber latex, which is helpful for patients who may be allergic. With AJOVY, there’s no loading dose, no dose titration, and it can be administered at home or in the office.

Let’s bring this back to your practice. Earlier I mentioned certain considerations you might make when evaluating patients for preventive migraine therapy. In summary, AJOVY may be an appropriate treatment option because it has an established safety profile, it’s not metabolized by cytochrome P450 enzymes, delivers sustained efficacy, and is available in an easy-to-use Autoinjector.

We hope you found this information helpful and consider AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine for your patients. To learn more about AJOVY or review the full Prescribing Information, please visit AJOVYhcp.com.

Hello - thanks for joining me today to learn more about long-acting protection against migraine with AJOVY. Before we get into it, allow me to introduce myself. I’m Dr Brad Torphy—Managing Director of Chicago Headache Center and Research Institute.

Something important to consider when prescribing a preventive migraine medication—will it wear off or last to the next dose? That’s why I want to talk to you today about AJOVY—the long-acting anti-CGRP injection with lasting protection against migraine.

As a reminder, AJOVY is indicated for the preventive treatment of migraine in adults. Please note, AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

During this presentation, we’ll take an in-depth look at the clinical trials to review how AJOVY demonstrated sustained efficacy, reductions in use of acute medication, and no evidence of wearing off from one dose to the next. Before reviewing the clinical results, let’s first look at the trial designs for both the HALO trial and the Long-Term Extension study. The HALO study consisted of two phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group trials. Patients were randomized in either AJOVY monthly dosing, AJOVY quarterly dosing, or the placebo arm, after which they underwent a screening visit, a 28-day preintervention, and a run-in period, followed by a 12-week intervention period, with final evaluation at Week 12.

Some of the patients in the 12-week HALO studies rolled over into the Long-Term Extension study—a 12-month, multicenter, randomized, double-blind, parallel-group clinical trial. The Long-Term Extension study was not placebo controlled, but patients were blinded as to the dosing regimen.

Please note, today we will only be looking at the episodic migraine results. If you’d like to see the results for chronic migraine, please visit AJOVYhcp.com.

The primary endpoint in the HALO episodic migraine trial was mean change from baseline in the monthly average number of migraine days for both monthly and quarterly dosing options during the 12-week period. As you can see, AJOVY demonstrated a statistically significant improvement in the mean reduction from baseline of 4.3 migraine days at month 3 versus 3.1 days for placebo. The Long-Term Extension study further demonstrated a mean reduction of 5.1 migraine days with monthly dosing. Similar results were observed for patients taking quarterly dosing.

Be aware that hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

I want to also mention a secondary endpoint of the HALO trial—change in use of acute medication. During the 12-week treatment period, patients with episodic migraine receiving the AJOVY monthly dosing regimen had a 3-day reduction in the average number of days of use of acute headache medication compared with 1.6 days for placebo. Similar results were also seen in chronic migraine. This endpoint tells us that patients taking AJOVY significantly decreased their need for acute medication. What might these data mean for your patients?

Now I want to take you through the post hoc analyses that showed no evidence of AJOVY wearing off from one dose to the next. To assess these dosing periods, data for patients with chronic and episodic migraine from the HALO trials who rolled over into the Long-Term Extension study were included in the post hoc analyses. We will, again, only be discussing the episodic patients.

The analyses looked at the mean number of weekly migraine days in patients on monthly dosing during months 3, 6, 9, and 15. Each of these months—3, 6, 9, and 15—was split into two: weeks 1 through 3, or the beginning of the dosing period, versus week 4, the end of the dosing period. Let’s look at the figures for the weekly average number of migraine days during weeks 1 through 3. And now, let’s compare them with the number of migraine days during week 4. As you can see, the weekly number of migraine days was similar between the beginning and the end of the dosing period, across all months shown. Note, for all post hoc analyses, no determination of statistical significance can be made, and no conclusions should be drawn.

Now, let’s think back to our consideration for preventive migraine therapy, “Will it wear off or last until the next dose?” With these data in mind, wouldn’t you consider AJOVY an appropriate option for your patients needing preventive therapy?

Of course, safety must be considered before making any decisions, so let’s take a look at those results from the HALO and Long-Term Extension studies. Shown here are the adverse reactions reported by at least 2% of patients on AJOVY and greater than placebo from the HALO trial.

In the Long-Term Extension study, you can see the adverse reactions that occurred in more than 6% of patients. It’s important to mention that no new safety signals were identified in the Long-Term Extension study.

Before we wrap things up, I want to remind you that patients have an option to take AJOVY either monthly or quarterly. Having such options may help your patients stay protected—whatever their lifestyle and schedules demand from them. You and your patients should decide together which option would be best.

Thank you for watching my presentation today. I hope the information I’ve shared helps you and your practice.

Remember, AJOVY is the long-acting anti-CGRP injection with lasting protection against migraine. If you need additional details, or the full Prescribing Information, please visit AJOVYhcp.com.

Introducing AJOVY (fremanezumab-vfrm) injection, indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

AJOVY (fremanezumab-vfrm) injection is a monoclonal antibody targeting the calcitonin gene-related peptide, or CGRP, ligand.

Patients experiencing migraine have increased levels of CGRP, a neuropeptide present in both the central and peripheral nervous system.

When CGRP binds to its receptor, a cascade of events result, which contribute to neurogenic inflammation that is associated with migraine pain.

This involves mast cell degranulation, vasodilation, and protein extravasation.

AJOVY selectively binds the CGRP ligand, which is believed to block this cascade of events, thereby preventing the activation of the trigeminal system.

CGRP plays an important role in the pathophysiology of migraine.

INDICATION
AJOVY is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection-site reactions.

Please see the full Prescribing Information at AJOVYhcp.com.

How to use the autoinjector for AJOVY® (fremanezumab-vfrm) injection.

Hi. I’m here to walk you through some instructions on how to use the autoinjector for AJOVY.

This video does not replace the complete Instructions For Use included with your autoinjector. Please read and follow the Instructions For Use before you start using your autoinjector for AJOVY and each time you get a refill.

If you still have questions after doing so, speak to your healthcare provider.

Preparing to use the autoinjector

Let’s get started. Whether you are injecting your AJOVY quarterly or once monthly, the process is very similar. First, remove your autoinjector from the refrigerator and wait for 30 minutes to allow the medicine to reach room temperature.

If your dose is 225 mg of AJOVY each month, remove one autoinjector.

If your dose is 675 mg of AJOVY every three months, take out three autoinjectors.

Do not shake the autoinjector.

Also, do not leave it in direct sunlight or try to warm it up using a heat source such as hot water or a microwave.

Now, wash your hands with soap and water and dry well with a clean towel.

Next, look closely at your autoinjector to make sure there is no visible damage such as cracks or leaks.

Ensure that the liquid inside is clear and colorless to slightly yellow.

If the liquid has any particles in it or is discolored, cloudy or frozen, do not use the autoinjector and call your healthcare provider or pharmacist.

If you see air bubbles in the autoinjector, don’t worry, as this is normal.

Be sure to check that “AJOVY” appears on the autoinjector and that the expiration date has not passed.

Choosing an injection area

You have a few options on where to inject your dose.

You can choose to inject your stomach area, but make sure to avoid about 2 inches around the belly button.

You can also inject in the front of either of your thighs at least 2 inches above the knee and at least 2 inches below the groin.

Or, you can inject on the fleshy areas at the back of either of your upper arms but you may need someone who has been instructed on how to give your injection to help you. If prescribed the 675 mg dose, avoid injecting in exactly the same place.

Using the autoinjector

To inject your dose of AJOVY, first clean the chosen injection area using a new alcohol swab and let your skin dry.

Now, pick up your autoinjector with one hand and pull the protective cap straight off with the other. Do not twist.

Throw the protective cap away immediately.

To give yourself the injection, place the blue end of the autoinjector at a 90-degree angle against your cleaned skin at the injection site.

Press down firmly on the autoinjector and you will hear a “CLICK” that means the injection has started.

Continue to hold down firmly for about 30 seconds.

As the medicine is being injected, the blue plunger will move to the bottom of the viewing window. After about 15 seconds, you will hear a second "CLICK."

Next, wait about 10 seconds to make sure all the medicine is injected.

Check that the blue plunger has filled the viewing window and remove the autoinjector from the skin by lifting straight up.

Now, use a clean, dry cotton ball or gauze pad to gently press on the injection site for a few seconds.

Put your used autoinjector in an FDA-approved sharps disposal or puncture-resistant container immediately after use.

Alright, there you have it. Please read the Instructions For Use. If you still have questions about these steps, I suggest speaking with your healthcare provider. You can also call the Shared Solutions® hotline at 1-800-887-8100 to be connected with a nurse who can answer your questions.

APPROVED USE

AJOVY is a prescription medicine used for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION

Do not use AJOVY if you are allergic to AJOVY or any of the ingredients in AJOVY. AJOVY may cause allergic reactions, including itching, rash and hives that can happen within hours and up to 1 month after receiving AJOVY. Call your healthcare provider or get emergency medical help right away if you have any symptoms of an allergic reaction: swelling of your face, mouth, tongue, throat or if you have trouble breathing. Talk to your doctor about stopping AJOVY if you have an allergic reaction. Tell your healthcare provider about all the medicines you take and if you are pregnant, planning to become pregnant, or are breastfeeding. Common side effects of AJOVY include injection-site reactions. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of AJOVY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at 1-800-FDA-1088. Please see the Patient Information Leaflet within the full Prescribing Information at AJOVY.com.