The FDA on Friday announced that it has cleared Eli Lilly's oral therapy Reyvow (lasmiditan) for the acute treatment of adults with migraine with or without aura. Eli Lily noted that Reyvow is "the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists)."
Approval of Reyvow for this indication was backed by data from two late-stage studies involving a total of 3177 adults with a history of migraine with or without aura. The FDA noted that data from both, the SPARTAN study, and the SAMURAI trial, showed that the percentage of patients whose pain and migraines symptoms resolved two hours after treatment were significantly greater among patients administered the oral 5-HT1F agonist compared to patients receiving placebo.
Eli Lilly submitted an application to the FDA seeking approval of the drug for the acute treatment of migraine, with or without aura, in adults in 2018. The company acquired rights to the 5-HT1F agonist as part of its $960-million takeover of CoLucid Pharmaceuticals the previous year.
Eli Lilly stated that Reyvow will be made available through retail pharmacies after the US Drug Enforcement Administration provides its controlled substance classification for the drug, which is expected to occur within 90 days. The company added that the price of the treatment will be clarified closer to the time of commercial launch.
The news comes after Eli Lilly gained FDA approval of Emgality (galcanezumab-gnlm) last year for the preventive treatment of migraine in adults. The indication for the CGRP inhibitor was later expanded in June to include the treatment of episodic cluster headache in adults. Sales of the therapy totalled $34.3 million in the second quarter.
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