An Update on Teva’s Highly Anticipated Migraine Drug

During Teva’s (TEVA) 1Q18 earnings release on May 3, the company provided an update on the approval and launch of its anti-CGRP (calcitonin gene-related peptide) monoclonal antibody Fremanezumab, a preventive migraine treatment. The company stated that it now doesn’t expect to get FDA (U.S. Food and Drug Administration) approval for Fremanezumab in mid-June as it had earlier estimated. The reason that Teva doesn’t expect approval in June is that Celltrion, which is Teva’s API (active pharmaceutical ingredients) supplier of Fremanezumab, got a warning letter from the FDA in 2017.