EMA accepts Teva’s Fremanezumab Marketing Authorization Application

Teva Pharmaceutical announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults. Fremanezumab is a quarterly or monthly injection that may be administered by a healthcare professional, or self-administered by the patient.

“The successful filing of the MAA for fremanezumab with the EMA builds on the momentum of the global fremanezumab program, following acceptance of the Biologics License Application with the U.S. Food and Drug Administration,” said Ernesto Aycardi, MD, Vice President Head of Clinical Trial Execution, Data Sciences and Biometrics & Clinical Pharmacology at Teva. “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. These two significant regulatory milestones in the migraine indication, combined with our clinical development programs for fremanezumab in cluster headache and post-traumatic headache, highlight Teva’s commitment to patients worldwide with these debilitating conditions.”

The MAA includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), evaluating both quarterly and monthly dosing regimens, in which fremanezumab achieved statistically significant results across all trial endpoints. The most common adverse events reported in clinical trials include injection site pain, induration, and erythema.