The European Medicines Agency (EMA) has accepted Teva’s marketing authorisation application (MAA) for its migraine prevention medicine fremanezumab.
Teva’s injection, an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody administered quarterly or monthly, is up for review to prevent episodic and chronic migraine in adults.
Ernesto Aycardi, vice president head of clinical trial execution at Teva, said: “With limited availability of preventive therapy options that target the underlying biological mechanisms of migraine, the MAA acceptance represents a major step toward advancing the treatment paradigm for the migraine community.”
The application seeking approval includes positive results from two-phase III trials in chronic migraine and episodic migraine, which – after evaluating both quarterly and monthly dosing regimens – found fremanezumab achieving statistically significant results across all trial endpoints.
More specifically the HALO trials – which were randomised, double-blind placebo-controlled studies – compared safety, tolerability and efficacy of the Teva’s medicine compared to placebo.
Aycardi continued: “These two significant regulatory milestones in the migraine indication, combined with our clinical development programmes for fremanezumab in cluster headache and post-traumatic headache, highlight Teva’s commitment to patients worldwide with these debilitating conditions.”
Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache as part of the phase III ENFORCE clinical research programme, which has been granted fast track designation by the US Food and Drug Administration (FDA).
Trials are expected to conclude in early 2019, and if all goes well with the studies then the Israeli pharma group could be gunning up for a big win, as it could potentially be the first to get approval of a cluster headache medication.
Cluster headaches – which are more commonly seen in men – normally come in sporadic episodes and suffers tend to feel severe pain along with a bunch of side effects including one red eye, smaller pupil in one eye and the drooping and swelling of one eyelid.