Development of Ajovy is discontinued in cluster headaches
Teva Pharmaceutical provided an update that the Company is discontinuing the clinical development program for use of Ajovy (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).
Comment: Ajovy was approved by the FDA in September 2018 for preventative treatment of migraine.
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