Lilly expands migraine offerings after FDA approval
Eli Lilly’s newest treatment is Reyvow (lasmiditan), a small molecule, oral medicine for the treatment of acute migraines, with or without aura, in adult patients.
The US Food and Drug Administration (FDA) approved Reyvow as a first-in-class treatment, which binds to 5-HT1F receptors, though the company noted that “the precise [therapeutic] mechanism is not known.”
Unlike Lilly’s Emgality (galcanezumab), which acts as a preventative treatment and reduces the number of episodic migraines, Reyvow is used at the onset of a migraine. The ‘aura’ mentioned as part of the treatment’s indication is a sensory or visual disturbance that can occur prior to, or during, a migraine.
In Phase III trials, the therapy was able to demonstrate sufficient efficacy in pain relief and freedom from other symptoms of migraines, including nausea and sensitivity to light or sound, to meet its endpoints.
As a result of Reyvow activating the central nervous system, the FDA required an abuse potential study of the treatment, which revealed patients had ‘less drug liking’ for Lilly’s treatment compared against alprazolam, also known by the brand name Xanax, but more drug liking than placebo.
Lilly will not be able to market the treatment until the Drug Enforcement Administration (DEA) has compared its review to determine controlled substance classification. The review is expected to be completed within 90 days, at which point the treatment can be marketed.