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.
Esperion settles with Dr. Reddy's Laboratories on NEXLETOL and NEXLIZET generics
Mint Pharmaceuticals forms distribution partnership with Bayer Canada
Padagis collaborates with The Naloxone Project to address opioid overdose crisis
Biocon's first US manufacturing facility inaugurated in Cranbury, New Jersey
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval