Eli Lilly and Co. said the U.S. Food and Drug Administration approved Reyvow for the treatment of certain migraine patients.
The regulatory agency authorized the use of Reyvow, or lasmiditan, as an acute therapy for migraine with or without aura in adults. In acute therapy, patients receive active but short-term treatment.
Migraine aura is categorized as sensory, motor or verbal disturbance in patients with migraine and is usually visual.
The approval is based on results from two phase 3 studies, named Samurai and Spartan, which showed that Reyvow was better than placebo for the acute treatment of migraine.
The U.S. regulator has identified driving impairment as a risk of taking Reyvow and has advised patients not to drive or operate machinery for at least eight hours after the treatment.
Indianapolis-based Lilly's migraine portfolio includes Emgality, or galcanezumab, which is approved by the FDA as a preventive treatment for migraine and as the first therapy for treating episodic cluster headache in adults.
