FDA Approves Lilly Migraine Drug

Lilly last month detailed plans to invest $850 million into its U.S. operations this year.

The U.S. Food and Drug Administration has given another approval for a drug from Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The approval of REYVOW is for the treatment of patients with acute migraines.

Lilly says the approval marks the first new class of acute migraine treatment approved by the FDA in more than two decades. The oral medicine first and only FDA-approved medicine in a new class of acute treatment for migraine.

“Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like REYVOW, which is why we are proud of today’s approval and Lilly’s continuing contribution to the migraine community,” said Gudarz Davar, M.D., vice president, neurology development, Lilly Bio-Medicines. “New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”

The recommended controlled substance classification for REYVOW is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which REYVOW will be available to patients in retail pharmacies.