Teva Provides Update on Fremanezumab Clinical Development for Use in Episodic Cluster Headache
24 April 2019 - - Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) has 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 four-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 programme 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).

Fremanezumab is a humanised monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor. Fremanezumab is considered an investigational compound in the treatment of cluster headache or post-traumatic headache and is not approved by any regulatory agency for those uses.

Teva Pharmaceutical Industries is in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area.


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