Teva Announces Submission of BLA for Fremanezumab to the U.S. FDA

Teva Pharmaceutical announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine.

“The BLA submission for fremanezumab marks a very important milestone for the migraine community,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “There have been few therapeutic innovations for migraine patients in over 25 years. If approved, fremanezumab will be among the first to enter the market in a new class of drugs for the preventive treatment of migraine. We are immensely proud of the progress we have made in the fremanezumab development program, and look forward to the potential to make this therapy available to the millions of people around the world who live with the debilitating effects of migraine.”

“Phase III clinical studies of fremanezumab demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in addition to demonstrating improvement in quality of life in patients living with episodic and chronic migraine,” said Ernesto Aycardi, M.D., Vice President, Therapeutic Area Head, Migraine & Headache at Teva. “We are very excited to have submitted the BLA to the FDA as an important step in being able to introduce a new therapy that may help to address a significant need in the migraine community for targeted, preventive treatment options.”

The BLA 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 monthly and quarterly dose regimens of fremanezumab. Results from these trials were recently presented at the Congress of the International Headache Society (IHC) in September and will be published in future peer-reviewed publications. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.