Ajovy™ Approved by FDA for Migraine Prevention in Adults

Ajovy™ (fremanezumab-vfrm) was approved by the FDA for the prevention of Migraine in adults on September 14, 2018. Ajovy™ was developed by Teva Pharmaceutical Industries Ltd. In a press release, Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva, commented:

“With limited availability of preventive treatment options, AJOVY provides physicians with an important new option for their patients, This approval furthers our ongoing commitment and experience in neurological conditions like migraine.”¹

Migraine experts comment on Ajovy™:

Stephen Silberstein, MD, Director, Jefferson Headache Center at Thomas Jefferson University Hospital, and lead investigator of the Phase III clinical trial program for Ajovy™ commented:

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”¹

Peter Goadsby, MD, PhD, DSc, a professor of neurology at the University of California San Francisco and King’s College London, commented:

“The future of the prevention of migraine is very bright. We have these new medicines, and we’re going to have others as we understand the pathways. I think there will be synergies. There may be synergies between the CGRP pathway and perhaps the pituitary adenylate cyclase activating polypeptide pathway, and there may be synergies between the ditans and the CGRP monoclonals, the gepants and the monoclonals—we’ve much to learn.”³

David Dodick, MD; director of the Headache Center at the Mayo Clinic in Scottsdale, Arizona, and lead investigator of the episodic Migraine trial of fremanezumab; offered his insights:

“What excites me about this class is that, for those who do respond, it’s very likely that the tolerability profile is such that they’re able to stay on the medication and they’re able to tolerate it and they might not have any adverse effects. The longer they stay on it, if you look at the one-year, open-label data for those that are staying on it, efficacy rates climb over time. The longer you’re able to adhere to a treatment that’s working for you, the better the patient outcome is over time. That’s the real difference here.”³

For a Migraine specialist’s perspective on what’s important for patients to know about Ajovy, I went to Dr. Stephanie J. Nahas. Dr. Nahas is the Director of the Headache Medicine Fellowship Program and Assistant Director of the Neurology Residency Program at the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. Dr. Nahas told me:

“Patients ask me if they are candidates for these new drugs. In my view, if someone has already tried at least two “standard” preventive medications yet is still significantly impacted by Migraine at least a few times per month (meaning disruption in their daily routine, ability to function, and reliability to work or care for others), that person is a candidate. There are many attractive aspects of monoclonal antibody CGRP blockers, including obviating the need to take a pill at least once a day or show up in a clinic once every 12 weeks. Additionally, interaction with other medications is not known to occur, and any adult who is not hypersensitive or allergic to them may benefit regardless of other medical or psychiatric comorbidities.

 

Patients also ask me what’s the difference among these new treatments besides the particular target of the antibody or mode of administration. They’re similar, but direct comparisons are impossible since each has been studied in isolation. With time and experience, we may elucidate more than just subtle differences, and with larger efforts such as the American Migraine Foundation Patient Registry (ARMR Study), we may begin to learn which types of patients may be more likely to respond to one treatment over another, taking some of the guesswork out of Migraine and Headache management.”

What is Ajovy™?

• Ajovy™ is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
• Ajovy™ is indicated for the prevention of Migraine in adults.
• It will be available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options:
  • 225 mg monthly administered as one subcutaneous injection, or
  • 675 mg every three months (quarterly), administered as three subcutaneous injections.
• Ajovy™ can be administered in office by a health care professional or at home by a patient or caregiver.
• The most common adverse reactions reported in clinical trials (≥5% and greater than placebo) were injection site reactions.
• Preliminary results from a follow-up study showed that one-year after beginning Ajovy™:²
  • chronic Migraine patients continued to experience fewer attacks each month,
  • but 10 to 12 percent of patients reported upper respiratory tract infections.

Access and pricing

• Ajovy™ will be available through retail and specialty pharmacies in approximately two weeks.
• The manufacturer suggested retail price for Ajovy™ is $575 per monthly dose and $1,725 per quarterly dose.
• There is a savings offer for Ajovy™ which allows commercially insured patients to pay as little as $0 on prescriptions for Ajovy™ until the offer expires. Teva Shared Solutions® is available to provide support services for patients and offices. Details will soon be available on AJOVY.com.

Teva released this video with information about Ajovy™:

Summary and implications for patients

With the earlier approval of Aimovig™ and now the approval of Ajovy™, we finally have treatments available that were developed specifically for Migraine prevention.

Both of these new treatments showed fewer side effects in clinical trials than we’re used to seeing from medications. This may be due to their being human or humanized antibodies as opposed to traditional medications. As with any new treatment, it’s too soon to know what long-term side effects, if any, may be revealed over time. Such is the case with any new treatment.

There are two more of these CGRP monoclonal antibody treatments to come for Migraine prevention. With research increasingly showing that CGRP plays a major role in Migraine, there are also acute treatments that target CGRP in development. Here’s a video in which Dr. Peter Goadsby discusses all of these treatments:

Sources:

1. Press Release. “Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults.” Teva Pharmaceutical Industries Ltd. Jerusalem. September 14, 2018.
2. George, Judy. “Fremanezumab Approved for Migraine Prevention.” MedPage Today. September 14, 2018.
3. Hoffman, Matt. “FDA Approves Fremanezumab for Migraine Prevention.” NeurologyLive. September 14, 2018.
4. Interview with Dr. Stephanie J. Nahas. September 19, 2018.