Originally, the late-stage trial featured the chronic cluster headache study, the episodic cluster headache study, along with a long-term safety study.
Teva’s decision to stop the chronic cluster headache study was based on a pre-specified futility analysis.
As per the analysis, the study’s primary endpoint, that of mean change from baseline in the monthly average number of cluster headache attacks, is unlikely to be met.
Teva said that there were no safety concerns with the 12-week long treatment of fremanezumab during the trial.
Teva senior vice president and global specialty clinical development head Tushar Shah said: “While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology.”
A monoclonal antibody, fremanezumab has been designed to target the calcitonin gene-related peptide (CGRP) ligand, which is considered to be a well-validated target in the neurological condition.
The drug is also being investigated by Teva as a preventive treatment for other disorders like cluster headache and post traumatic headache disorder.
Currently, fremanezumab is under review by the US Food and Drug Administration (FDA) and also by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.
Teva’s Biologics License Application (BLA) with the FDA and its marketing authorization application (MAA) with the European Medicines Agency (EMA) for fremanezumab were based on the findings from the phase 3 HALO program and others. The HALO program was held in more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM).
Image: Israel-based Teva is awaiting approval for its migraine drug fremanezumab in the US and European Union. Photo: courtesy of Teva Pharmaceutical Industries Ltd.