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Lilly's Lasmiditan NDA Review Could Hinge On US FDA's Migraine Guidance

 
• By Bridget Silverman

Potential first-in-class on-demand oral migraine treatment would complement new prevention products from Lilly, Amgen and Teva. 

Migraine word written on wood block

The US review of Eli Lilly & Co.’s lasmiditan new drug application (NDA) will be the first significant test of FDA's final guidance on development of acute treatments for migraine.

Released in February 2018, the guidance is part of the agency's modernization of the Center for Drug Evaluation and Research's Office of New Drugs so that it has a more "team-based approach

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