Teva has decided to discontinue part of the ENFORCE Phase 3 clinical development program for fremanezumab after a pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint (mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period) was unlikely to be met.
According to the Company no safety concerns were observed with fremanezumab during the chronic cluster headache trial. In a press release, Tushar Shah, MD, Senior Vice President, Head of Global Specialty Clinical Development at Teva said “While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology.”
The ENFORCE Phase 3 clinical development program also includes a study involving patients with episodic cluster headache. The 13-week, multicenter, randomized, double-blind, placebo-controlled trial is investigating the efficacy and safety of 2 dose regimens of fremanezumab in adult patients for the prevention of episodic cluster headache. The primary endpoint of the study is mean change from baseline in the weekly average number of cluster headache attacks during the 4-week period after administration of the first dose of fremanezumab.
Fremanezumab, an anti-CGRP monoclonal antibody, is currently being reviewed by the Food and Drug Administration (FDA) as a quarterly or monthly injection for the preventive treatment of migraine in adults. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab for this indication is set for September 16, 2018.
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