Teva To Discontinue Clinical Trial Of Fremanezumab For Chronic Cluster Headache

(RTTNews) - Israeli generic medicines producer Teva Pharmaceutical Industries (TEVA) announced Friday that it will discontinue the trial of fremanezumab for use in chronic cluster headache, which is part of the larger ENFORCE Phase III clinical development program.

A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. There were no safety concerns observed with the trial.

However, Teva said it will continue the trial of fremanezumab for use in episodic cluster headache, and a long-term safety study that were part of the ENFORCE Phase III clinical development program.

Fremanezumab is a monoclonal antibody targeting the CGRP (calcitonin gene-related peptide) ligand.

Fremanezumab is currently under review by the U.S. Food and Drug Administration (FDA), with an action date of September 16, 2018, and by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.

Fremanezumab is also being investigated as a preventive treatment for several additional disorders including cluster headache and post traumatic headache disorder.