New Drug Application Submitted for Lasmiditan for Acute Treatment of Migraine

Eli Lilly has submitted a New Drug Application (NDA) to the FDA for lasmiditan for the acute treatment of migraine with or without aura in adults, according to a company press release.

If approved, lasmiditan would be the first significant advancement for the acute treatment of migraine in more than 2 decades, Lilly stated in the release. Lasmiditan uses a novel mechanism that selectively targets 5-HT1F, including those expressed in the trigeminal pathway. As opposed to other therapies, lasmiditan has been designed to treat migraines without the vasoconstrictor activity.

Additionally, Lilly also received Breakthrough Therapy Designation for glacanezumab-gnlm (Emgality) for the prevention of episodic cluster headache. The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA for this indication by the end of the year. Glacanezumab-gnlm was approved in September for the preventive treatment of migraine in adults.

The NDA for lasmiditan includes data from two phase 3 studies, SAMURAI and SPARTAN. Both trials evaluated the safety and efficacy of lasmiditan for the acute treatment of migraine.

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