Teva announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for fremanezumab for the prevention of migraine.
Fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody, was evaluated in the Phase 3 HALO EM and CM studies, which enrolled >2000 adults with episodic and chronic migraine. The 16-week, randomized, double-blind, placebo-controlled, parallel-group studies looked at the safety, tolerability, and efficacy of 4 dose regimens of subcutaneous fremanezumab vs placebo in adults with chronic and episodic migraine.
In HALO EM (n=875), patients were randomized to fremanezumab 225 mg for 3 months (monthly regimen), fremanzeumab 675 mg at initiation plus placebo for 2 months (quarterly dose regimen), or 3 monthly doses of matching placebo. The primary efficacy endpoint was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab.
In HALO CM (n=1130), patients were randomized to fremanezumab 675 mg at initiation plus 225 mg monthly for 2 months (monthly dose regimen), fremanezumab 675 mg at initiation plus placebo for 2 months (quarterly dose regimen), or 3 monthly doses of matching placebo. The primary efficacy endpoint was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.
Ernesto Aycardi, MD, Vice President, Therapeutic Area Head, Migraine & Headache, Teva, stated, “Phase III clinical studies of fremanezumab demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in addition to demonstrating improvement in quality of life in patients living with episodic and chronic migraine.” Data will be published in future peer-reviewed publications.
The most frequent adverse effects observed in clinical studies included injection site induration, erythema, and pruritus.
Teva announces submission of biologics license application for fremanezumab to the US FDA [press release]. Jerusalem: TEVA; Accessed November 1, 2017.
This article originally appeared on MPR