The Biologics License Application (BLA) for the investigational migraine treatment, fremanezumab (Teva), has been accepted for review by the Food and Drug Administration (FDA).

Fremanezumab is an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody. The application includes data from the Phase 3 HALO EM (N=875) and CM (N=1130), which were randomized, double-blind, placebo-controlled trials lasting 16-weeks. Both quarterly and monthly dosing regimens of fremanezumab achieved statistically significant results across the study endpoints (reduction in frequency of migraine/headache days). 

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“We look forward to the potential to make fremanezumab commercially available for the prevention of migraine for patients in the U.S. next year,” said Marcela Bigal, MD, PhD, CSO at Teva. The Company expects regulatory action by the middle of 2018.

Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache.

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