Lilly Announces FDA Approval of Reyvow (lasmiditan), the First and Only 5-HT1F Receptor Agonist for Acute Treatment of Migraine in Adults

Today, Eli Lilly and Company announced that the U.S. FDA has approved the company’s developed Reyvow (lasmiditan) tablets for marketing as an acute treatment for adult migraine patients with or without aura. Reyvow has a unique mechanism of action and is the first and only serotonin (5-HT) 1F receptor agonist approved by the FDA. The press release pointed out that this is the first new class of drugs approved by the FDA for the acute treatment of migraines in over 20 years.

Migraine is a neurological disorder characterized by severe headache attacks, with other symptoms accompanying the headache including nausea and sensitivity to sound and light. More than 10% of the world's population suffers from migraines, and women are three times more likely to be affected than men. Although there are currently various medications for treating and preventing migraines, the condition remains underrecognized and undertreated. Statistics show that nearly 40% of migraine patients have an inadequate response to their first acute therapy.

Reyvow, developed by Eli Lilly and Company, is an innovative oral 5-HT1F receptor agonist. It binds to the 5-HT1F receptor with high affinity. Reyvow (lasmiditan) is the first “ditan” class medication approved by the FDA. Currently, the common acute therapies for migraine are triptans, which are 5-HT1B/1D receptor agonists. Although they demonstrate significant efficacy in alleviating migraines, activation of the 5-HT1B receptor subtype induces vasoconstriction, leading to other side effects. Reyvow does not activate the 5-HT1B receptor and therefore does not cause vasoconstriction. This makes it a safer option for migraine patients with cardiovascular disease or those at risk of cardiovascular disease.

▲ Molecular structure of lasmiditan (Image source: Anypodetos [Public domain])

The efficacy of Reyvow was validated in two randomized, double-blind, placebo-controlled Phase 3 clinical trials (SAMURAI and SPARTAN). A total of 3,177 patients with a history of migraine participated in these trials. The results demonstrated that, compared with the placebo group, the proportion of patients achieving complete headache relief two hours after dosing was significantly higher in the Reyvow group. Reyvow also significantly alleviated other most bothersome migraine symptoms, namely nausea and photophobia/phonophobia. Notably, Reyvow exhibited favorable efficacy in the subgroup of patients who had an inadequate response to triptans.

▲Partial Efficacy Results of Reyvow in Phase 3 Clinical Trials (Image Source: Reference Materials)^[3]）

“Millions of migraine patients struggle daily with intractable pain and other migraine symptoms. There remains a significant unmet need in the acute treatment of migraine. We are proud of today’s approval, and Eli Lilly will continue to benefit patients with migraine,” said Dr. Gudarz Davar, Vice President of Neurology Development at Eli Lilly Biomedicines. “We have new expectations for migraine treatment, with pain freedom being the therapeutic goal for both patients and physicians. Eli Lilly will continue to develop innovative products to provide new treatment options for patients with migraine.”

References:

[1] FDA approves new treatment for patients with migraine. Retrieved October 11, 2019, from https://www.prnewswire.com/news-releases/fda-approves-new-treatment-for-patients-with-migraine-300937273.html

[2] Lilly's REYVOW™ (lasmiditan), The First and Only Medicine in a New Class of Acute Treatment for Migraine, Receives FDA Approval. Retrieved October 11, 2019, from https://www.prnewswire.com/news-releases/lillys-reyvow-lasmiditan-the-first-and-only-medicine-in-a-new-class-of-acute-treatment-for-migraine-receives-fda-approval-300937322.html

[3] 2018 Investment Community Meeting. Retrieved October 11, 2019, from https://investor.lilly.com/static-files/e1cc74de-ada5-4ae4-b5a4-7ecf0969197d

[4] Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache. Retrieved October 11, 2019, from https://investor.lilly.com/news-releases/news-release-details/lilly-submits-new-drug-application-fda-lasmiditan-acute

[5] Therapeutic novelties in migraine: new drugs, new hope? Retrieved October 11, 2019, from https://doi.org/10.1186/s10194-019-0974-3

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