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Teva Pushes CGRP Timeline Back To End Of 2018

 
• By Jessica Merrill

Management said the migraine drug fremanezumab could launch in the US by the end of the year following discussions with the US FDA. The June timeline has been delayed by a Celltrion manufacturing issue.

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Teva Pharmaceutical Industries Ltd. has pushed back the timeline for launching the migraine drug fremanezumab in the US, but still expects the CGRP drug could launch by the end of the year. Management updated investors on the expectations for the launch during a first quarter earnings call May 3 after previously warning the launch could be delayed due to a manufacturing issue at Celltrion Inc., which is manufacturing an active ingredient for fremanezumab.

In February, Teva said the issues at Celltrion could delay FDA action on fremanezumab beyond the June 16 user fee date, disappointing news for the company, which is facing various business challenges. (Also see "Bad News Teva Really Doesn't Need: A Potential Delay For Fremanezumab" - Scrip, 8 February, 2018

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