Thursday, October 11, 2018

FDA approves fremanezumab and galcanezumab for migraine

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.
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…

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.


The US Food and Drug Administration (FDA) has approved the calcitonin gene–related peptide (CGRP) antagonist galcanezumab-gnlm (Emgality, Eli Lilly and Co) for the prevention of migraine in adult patients, the manufacturer reports.

This marks the agency's third approval this year of an anti-CGRP for this indication, following earlier approvals of erenumab (Aimovig, Amgen and Novartis) and fremanezumab-vfrm (Ajovy, Teva).

The humanized monoclonal antibody also received recommended marketing authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use last week.

The FDA's approval is for a 120-mg self-administered, subcutaneous injection of galcanezumab. The recommended dose is 240 mg once as a loading dose, administered in two consecutive injections of 120 mg each, followed by monthly injections at 120 mg…

As reported at the time by Medscape Medical News, detailed results from three phase 3 trials that assessed galcanezumab were presented at the 2017 American Headache Society Annual Scientific Meeting.

In EVOLVE-1 and EVOLVE-2, which together included more than 1700 patients with episodic migraine, the participants who received 120 or 240 mg of the active drug experienced significantly greater reductions in monthly migraine headache days than those who received matching placebo.

Similar results were shown in the REGAIN trial, which included more than 1100 patients with chronic migraine.

Adverse events reported in the three studies included injection site pain, reactions, and erythema.

The company reports that the US list price for the drug will be $575 once monthly or $6900 annually. However, "patients with commercial insurance are candidates to receive Emgality for up to 12 months free as part of Lilly's patient support program," said the manufacturer.


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