Teva Announces Update on Fremanezumab Clinical Development for use in Episodic Cluster Headache

Teva Pharmaceutical Industries Ltd. provided an update that the Company is discontinuing the clinical development program for use of fremanezumab in cluster headaches. A pre-specified futility analysis of a Phase III study in episodic cluster headache revealed that the study’s primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period is unlikely to be met.

As a result of the above, Teva is discontinuing the ENFORCE Phase III clinical trial program, which also includes a long-term safety study. The program previously included a chronic cluster headache study, which was discontinued in June of 2018. Teva continues to explore other uses for fremanezumab, including the treatment of post-traumatic headache (currently being studied in a Phase II trial).

“We’d like to thank the patients and investigators for their immense contributions to this study.Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva.