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FDA approves Lilly’s migraine drug Reyvow

Two phase 3 clinical trials show positive data

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The FDA has approved Eli Lilly’s lasmiditan in the treatment of adults with acute migraines, with or without aura.

Lasmiditan, which Lilly will market as Reyvow, is the first serotonin 5-HT1F receptor agonist to come to market. Researchers first linked serotonin to migraines in the late 1950s, although Lilly is unsure of Reyvow’s precise mechanism of action.

Lilly is more confident about the outcomes. Across two phase 3 clinical trials, Lilly linked Reyvow to improvements in pain freedom and the patient-selected most bothersome symptom in the two hours after treatment.

On the safety front, Reyvow was primarily associated with mild to moderate treatment emergent adverse events such as dizziness, fatigue, paresthesia and sedation. The overall dataset was strong enough to persuade the FDA to approve the drug.

Lilly now needs to wait for up to 90 days for the Drug Enforcement Administration (DEA) to review the recommended controlled substance classification. Once the DEA has completed its review, Lilly plans to make Reyvow available to patients in retail pharmacies.

Reyvow will join another recently approved migraine product, the CGRP antagonist Emgality, in Lilly’s franchise. Lilly won the Emgality approval in September 2018, putting it behind Amgen and Novartis’ Aimovig and Teva Pharmaceutical Industries’ Ajovy in the race to bring a CGRP antagonist to market.

While Lilly was a latecomer to the CGRP antagonist market, it became the first company to get such a drug approved in the treatment of episodic cluster headache in adults in June.

Emgality ended the second quarter with a 41% cut of the new to brand market, racking up sales of $34m (£27m) in the process. Early uptake of the drug was supported by Lilly’s offer to provide the drug free of charge for the first 12 months.

Getting Reyvow to market will give Lilly the means to sell to a larger slice of the migraine market.

“Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like Reyvow is an important development for physicians and the patients we treat,” Jan Brandes, assistant clinical professor at Vanderbilt University’s Department of Neurology, said in a statement.

The approval gives Lilly a chance to start recouping some of its outlay on lasmiditan. Lilly discovered the molecule but outlicensed it to CoLucid Pharmaceuticals in 2005. More than a decade later, Lilly paid $960m to acquire CoLucid and regain full control of lasmiditan.

Article by
Phil Taylor

14th October 2019

From: Research



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