Teva files potential blockbuster migraine drug for FDA approval

Shares of Israeli generics giant Teva Pharmaceutical Industries  (NYSE: TEVA) edged up nearly 1%, after the company revealed that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine.

Teva acquired rights to fremanezumab from Heptares, a subsidiary of Japanese drugmaker Sosei Group (TYO Mothers Index: 4565), under the terms of a potential $400 million licensing and drug-discovery agreement reached in 2015. Earlier this year Teva sub-licensed the drug to Japan’s Otsuka Pharmaceutical (TYO: 4578) for the Japanese market.

“The BLA submission for fremanezumab marks a very important milestone for the migraine community,” said Michael Hayden, president of global R&D and chief scientific officer at Teva, adding: “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.”