Teva reveals delay in migraine timeline, reports earnings

Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said in its 1Q18 earnings that it does not expect FDA to approve its BLA for migraine prophylactic candidate fremanezumab (TEV-48125) on its mid-June PDUFA date. The company expects an FDA inspection to take place “in the coming months” and is targeting a launch this year.

On a conference call Wednesday, Teva CEO Kåre Schultz said the delay is due to a warning letter received by Celltrion Inc. (KOSDAQ:068270), the sole provider of fremanezumab API. The mAb targeting calcitonin gene-related peptide (CGRP) ligand is under Priority Review by FDA, as well as EMA review. The company expects a decision in Europe in 1H19 (see BioCentury Extra, Dec. 18, 2017)...