Lilly Gets FDA Approval For New Oral Tablets For Migraine

 | Oct 13, 2019 10:14PM ET

Eli Lilly & Company (NYSE:LLY) announced that the FDA has approved lasmiditan for the treatment of acute migraine headaches, with or without aura, in adults. Lasmiditan, an oral 5-HT1F agonist, is the first and only FDA-approved medicine in this class of migraine drugs. Lasmiditan will be marketed by the trade name of Reyvow and will be available in oral doses of 50 mg, 100 mg, and 200 mg, once launched.

The new drug application for Reyvow was based on data from two phase III studies, SAMURAI and SPARTAN. Both the studies met the efficacy endpoints. Data from the studies showed that treatment with Reyvow led to pain freedom and freedom from most bothersome symptoms of migraine at two hours after administration of Reyvow compared to placebo.

Please note that lasmiditan was added to Lilly’s portfolio with the 2017 acquisition of CoLucid Pharmaceuticals.

Year to date, Lilly’s shares have declined 6.3% compared with the Zacks Investment Research

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