New CGRP antagonist 'eptinezumab' expected to be marketed

Lundbeck reports that the drug met primary endpoints in the Phase 3 SUNRISE trial

Will begin the process for obtaining approvals in key Asian countries, including KOR

Product photo of Lundbeck

Yet another CGRP antagonist drug for migraine is expected to be marketed.

 

Lundbeck's 'eptinezumab (Vyepti),' a CGRP antagonist for the preventive treatment of migraine, showed positive results in the global Phase 3 clinical trial in Asia involving Koreans.

 

The drug is expected to enter South Korea quickly based on this result.

 

Lundbeck has announced that in the Phase 3 pivotal SUNRISE trial, which was conducted to evaluate the efficacy and safety of the drug in patients with chronic migraines, eptinezumab met primary and all key secondary endpoints.

 

Lundbeck's eptinezumab is an intravenous (IV) therapy used for preventive migraine treatment, sold in Europe and the United States.

 

It was approved by the U.S.

 

Food and Drug Administration (FDA) as a preventive migraine treatment in adults in February 2020.

 

In January 2022, it received marketing authorization from the European Medicines Agency (EMA).

 

Eptinezumab is being sold in over 30 markets worldwide in addition to the U.S.

 

market.

 

Ahead of its launch in Asia, Lundbeck achieved positive outcomes from the SUNRISE clinical trials.

 

The SUNRISE clinical trial enrolled adult patients with chronic migraines who required preventive treatment.

 

Symptoms of chronic migraine were defined as having a headache lasting more than 15 days in a month, with migraines occurring more than 8 days in a month.

 

In a randomized, double-blind clinical trial, 983 patients were randomized and double-blinded to three treatment groups to receive eptinezumab 300 mg, 100 mg, or placebo by IV infusion.

 

The effects were monitored for 12 weeks.

 

The SUNRISE clinical trial results showed that eptinezumab significantly reduced monthly migraine days (MMD) compared to the placebo, meeting the primary endpoint.

 

Measuring changes to MMD in chronic migraines during the 12-week treatment showed that the 300 mg-administered patient group had -7.5 days, the 100 mg-administered patient group had -7.2 days, whereas the placebo patient group had -4.8 days.

 

Additionally, the eptinezumab 300 mg-or 100 mg-administered patient group had a significant MMD reduction of over 50% during the 12-week treatment compared to the placebo.

 

In the SUNRISE clinical trial, the percentage of patients experiencing migraines the next after the eptinezumab infusion was significantly lower than the placebo, confirming that eptinezumab's preventive effects are experienced early.

 

"In Asia, millions of people are affected by frequent and severe migraines, but only a few individuals use preventive therapy due to limitations of efficacy, safety, and drug tolerance," Johan Luthman, Executive Vice President in the R&D sector, stated.

 

"We are very pleased with the SUNRISE clinical trial results.

 

The current results will play a key role in Lundbeck's effort in providing eptinezumab to Asian patients who suffer from severe migraines," Luthman added.

 

Meanwhile, Lundbeck plans to initiate the process of obtaining approval from the regulatory authority so that patients in Asia regions, including South Korea, China, and Japan, who suffer from migraines can readily use eptinezumab.