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Keeping Track: Two Novel Migraine Drugs Highlight Busy Week For US FDA Approvals

 
• By Bridget Silverman

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Feature image
• Source: Shutterstock

The US Food and Drug Administration’s approval of two novel migraine therapies – Biohaven Pharmaceutical Holding Co. Ltd.'s Nurtec ODT (rimegepant) and Lundbeck Inc.'s Vyepti (eptinezumab-jjmr) – in the space of a week continues the fast expansion of the calcitonin gene-related peptide (CGRP) inhibitor class, which debuted less than two years ago and now counts six FDA-approved agents.

Other highlights of the Center for Drug Evaluation and Research’s activities include approval of a new anti-emetic, Acacia Pharma Group PLC’s Barhemsys (amisulpride), a cardiovascular risk reduction indication for Lilly Research Laboratories’s glucagon-like peptide-1 (GLP-1) agonist Trulicity (dulaglutide), a third-line combination therapy indication for Puma’s Nerlynx (neratinib) in HER2-positive breast cancer, and

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