The New Drug Application (NDA) for lasmiditan (Lilly), an investigational oral treatment for migraine, has been submitted to the Food and Drug Administration.

Lasmiditan is a centrally-penetrant, selective serotonin 5-HT1F agonist designed for the acute treatment of migraine without the vasoconstrictor activity associated with some other migraine therapies. The NDA submission included data from two Phase 3 trials, SAMURAI and SPARTAN. Results across both studies showed that a significantly greater percentage of patients treated with lasmiditan were migraine pain-free 2 hours following the first dose vs those who received placebo. In addition, compared with placebo, more patients in the lasmiditan group were found to be free of their most bothersome symptom at 2 hours following the first dose.

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“We are thrilled to be one step closer to potentially providing new and different options with lasmiditan for the acute treatment of migraine,” said Gudarz Davar, MD, vice president, Neurology Development, Lilly Bio-Medicines.

The Company also announced plans to submit a supplemental Biologics License Application (sBLA) for Emgality (galcanezumab-gnlm) for the prevention of episodic cluster headaches in adults; the treatment was granted Breakthrough Therapy designation for this indication. Emgality, a calcitonin gene-related peptide (CGRP) antagonist, was approved in September 2018 to prevent migraines in adults.

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