Lundbeck receives marketing authorization for Vyepti® (eptinezumab) in South Korea for the preventive treatment of migraine

H. Lundbeck A/S has received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for eptinezumab. The treatment is indicated for the preventive management of migraine in adult patients.

This regulatory approval allows the biopharmaceutical company to introduce a humanized monoclonal antibody designed for intravenous administration into the Korean market. The decision follows a series of confirmatory Phase 3 trials, including PROMISE-1, PROMISE-2, and DELIVER.

Addressing a Significant Healthcare Gap

The authorization arrives at a critical time, as approximately 11% of the South Korean population currently lives with migraine. This figure may be an underestimation of the actual prevalence within the region.

Despite the high number of affected individuals, preventive treatments in Korea are often underutilized. Significant gaps remain regarding diagnosis and access to effective care options for those suffering from the disease.

Did You Know? Migraine is considered the leading cause of disability for people under the age of 50 and the second leading cause of disability worldwide.

Clinical Foundations and Regional Efficacy

A key component of the approval was the SUNRISE trial, a randomized, placebo-controlled Phase 3 study. This specific trial was conducted in a predominantly Asian population with chronic migraine to ensure efficacy within the target demographic.

Eptinezumab works by binding to the calcitonin gene-related peptide (CGRP). Clinical data showed a decrease in monthly migraine days over a 12-week period for both episodic and chronic migraine patients.

Expert Insight: Samantha Carter notes that the inclusion of the SUNRISE trial is a strategic necessity for market penetration in Asia. By validating the drug’s performance in a regional population, Lundbeck strengthens its clinical narrative and addresses specific patient needs in a market where preventive care has been historically underserved.

Global Market Expansion

The South Korean authorization expands the global footprint of eptinezumab, which has already been launched in more than 30 markets. The treatment first received approval from the U.S. Food and Drug Administration in February 2020.

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Following the U.S. Launch, the European Commission granted marketing authorization in January 2022 for adults experiencing at least four migraine days per month.

Future Implications

With this new authorization, Lundbeck may see an increase in its ability to deliver innovative therapies across Asia. The company could potentially reduce the disease burden for patients who have previously lacked adequate preventive options.

As the treatment becomes available, It’s likely that healthcare providers in Korea will have a new tool to break the cycle of acute medication overuse, which can otherwise lead to the chronification of the disease.

Frequently Asked Questions

What is eptinezumab and how is it administered?
Eptinezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) and is specifically designed for intravenous (IV) administration.

What were the primary results of the clinical trials?
In the PROMISE-1 and PROMISE-2 trials, the treatment met its primary endpoint of decreasing monthly migraine days over weeks 1-12. Benefit over placebo was observed as early as Day 1 post-infusion for both 100 mg and 300 mg doses.

What are the common adverse reactions associated with the treatment?
The most common adverse reactions identified in clinical trials were hypersensitivity, and nasopharyngitis. Approximately 1.9% of patients in the PROMISE-1 and PROMISE-2 trials discontinued treatment due to adverse reactions.

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