Eli Lilly Gets FDA Nod for Its New Migraine Drug, Lasmiditan

“At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”


The U.S. Food and Drug Administration (FDA) has approved a new drug called lasmiditan for the treatment of acute migraines. Sold under the brand name Reyvow, Eli Lilly develops lasmiditan.

Lasmiditan belongs to the class of drugs called serotonin (5-HT1F) receptor agonist, which has been increasingly competitive in the market of migraine medications.

The drug works through a different mechanism from the group of previously approved preventive medications such as Lilly’s galcanezumab (Emgality), Allergan’s ubrogepant, Teva, and Novartis/Amgen.

The Indiana-based pharmaceutical company said the approval of lasmiditan has marked the “first new class of acute migraine treatment” in more than 20 years.

Lasmiditan is the first and only FDA-approved oral drug for acute migraine treatment.

Dr. Gudarz Davar, vice president of the neurology development of Lilly Bio-Medicines, said, “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.”

“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,” added Dr. Davar. “At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”

Just like all medications acting on the central nervous system, lasmiditan will undergo abuse potential studies because the FDA has been concerned about the prescription drug addiction because of the ongoing drug overdose epidemic across the United States.

The Drug Enforcement Administration (DEA) will be reviewing the recommended controlled substance classification for lasmiditan, which is expected within 90 days of approval from the FDA. Clinical trials of lasmiditan showed a few side effects that were mild to moderate, such as fatigue, dizziness, tingling or numbing, sleepiness, drowsiness, nausea or vomiting, and muscle weakness.