Posted by Michael Wonder on 18 Dec 2017
FDA accepts biologics license application for fremanezumab with priority review for prevention of migraine and grants fast track designation for cluster headache development program
18 December 2017 - Teva anticipates launching anti-CGRP product in the U.S. for the prevention of migraine in 2018.
Teva Pharmaceutical Industries today announced the U.S. FDA has accepted for review the company’s biologics license application for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine.
Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.
