FDA Approves Fremanezumab (Ajovy) for Migraine Prevention

Deborah Brauser

Disclosures

September 17, 2018

The US Food and Drug Administration (FDA) has approved the humanized monoclonal antibody fremanezumab-vfrm (Ajovy, Teva Pharmaceuticals) for migraine prevention in adults, the manufacturer has announced.

The injectable calcitonin-gene-related peptide (CGRP) antagonist "is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675 mg) and monthly (225 mg) dosing options," the company said in a press release.

As reported by Medscape Medical News, in May the FDA approved the self-injectable erenumab (Aimovig, Amgen and Novartis) as the first CGRP antagonist for this indication. It's now offered as once-monthly 70- or 140-mg single-use prefilled autoinjectors.

Stephen Silberstein, MD, director of the Jefferson Headache Center at Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania, noted in Teva's press release that the FDA's new approval of a second anti-CGRP is good news for patients.

"About 40% 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," Silberstein said.

Reduced Monthly Headache Days

At the 2017 American Headache Society Annual Scientific Meeting, investigators presented detailed results from two phase 3 studies of fremanezumab.

More than 1000 patients with chronic migraine (CM) were enrolled in the HALO-CM trial. Those who were randomly assigned to receive 675 mg of the active treatment for 1 month followed by either 225-mg dose treatments for the following 2 months ("monthly dosing") or placebo for the next 2 months ("quarterly dosing") had a significantly reduced number of monthly headache days (4.6 and 4.3 days, respectively) compared with those who received only three monthly placebo injections (2.5 days; P < .0001 for both comparisons).

In addition, 873 patients with episodic migraine (EM) were enrolled in the HALO-EM trial. Both the monthly and quarterly dosing groups met the study's primary endpoint of greater reduction in monthly migraine days at 12 weeks vs the placebo group (by 3.7 and 3.4 days, respectively, vs 2.2 days; P < .0001).

The most common treatment-related adverse events were injection-site reactions and infections, a statement from the FDA notes.

The drug is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or any of the excipients, the agency adds. Hypersensitivity reactions to treatment, including rash, pruritis, drug hypersensitivity, and urticaria, were reported in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment and were apparent within hours or the first month of administration. 

Teva reports that the treatment, which can be administered in a physician's office or at home, will become available in about 2 weeks — and notes that the US wholesale acquisition cost of the treatment is $575 per monthly dose and $1725 per quarterly dose. However, the company notes that "commercially insured patients may pay as little as $0 on prescriptions until the offer expires."

In addition to fremanezumab and erenumab, two other anti-CGRP antibody treatments are in various stages of development. Galcanezumab (Lilly) is currently under review, with a PDUFA date listed as "September 2018." The manufacturer of eptinezumab (Alder BioPharmaceuticals) is expected to file for FDA approval by the end of 2018.

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