Eli Lilly's Reyvow wins FDA nod for migraine relief, but side effects could limit sales: analyst

Eli Lilly is already working to grow market share for its migraine prevention med Emgality, but now the company has a new medicine to add to its suite. 

Reyvow, a first-in-class drug Lilly picked up with its 2017 CoLucid buyout, won approval Friday to treat migraines as they occur. Formerly known as lasmiditan, Reyvow will be the latest launch for the company's growing pain and migraine franchise.

Lilly Bio-Medicines President Patrik Jonsson said in a statement the nod is “an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens." The company's own Emgality, along with its CGRP brethren, is approved as a migraine-prevention agent, but not to treat acute migraine.

The FDA approved Reyvow based on two trials in a total of more than 3,100 patients. In the studies, patients who took Reyvow were more likely to have their migraine symptoms resolved after two hours than those who took placebo. 

RELATED: Eli Lilly files for FDA approval of migraine drug lasmiditan

In a note to clients, SVB Leerink analyst Marc Goodman said the new drug has “solid efficacy” and should be a “welcome" addition for doctors and patients, but that its label and side effects will prevent it from being a “significant” drug revenue-wise. Instead, he believes it’ll be a niche medicine with under $500 million in peak sales. 

Reyvow’s side effects include dizziness and somnolence, and Goodman notes that the Drug Enforcement Agency will have to schedule the new med before it can launch. The label also says patients shouldn’t drive for at least 8 hours after taking the drug.  

Lilly shelled out $960 million for Reyvow's developer, CoLucid, in 2017 and filed the drug for approval last November. 

RELATED: Don't fret about Lilly's 3rd-to-market start in CGRP, executive says. It's got big plans in migraine and pain

Meanwhile, even though Emgality was the third CGRP drug to win FDA approval and trailed rivals to launch, it’s been growing market share quickly in recent months. It held 31% of the treatment category as of mid-August. The drug also picked up a cluster headache nod in June.