Lundbeck Seeks Approval for Vyepti in Asian Markets
H. Lundbeck A/S (Lundbeck) has taken a significant step by submitting a new drug application (NDA) for Vyepti (eptinezumab) to Japan's Ministry of Health, Labor and Welfare (MHLW). This submission represents a remarkable opportunity to broaden access to an innovative preventive treatment for migraine patients throughout Japan, while similar applications have also been filed in China and South Korea.
Clinical Support for Vyepti's Launch
The applications across these Asian territories are supported by data from the Phase 3 SUNRISE trial, which has confirmed the efficacy of eptinezumab in preventing migraines among Asian patients. The acceptance of these applications represents a major achievement in Lundbeck's Focused Innovator strategy, which emphasizes enhancing operational capabilities throughout Asia and confirming the company's leadership role in the migraine treatment landscape.
Impact of Migraine in Asia
Though migraine affects millions in Asia just as it does in Western countries, the region faces distinct challenges regarding adequate diagnosis and treatment. Reports indicate that a substantial percentage of individuals with migraines in Japan—and even higher in Korea—have never consulted a physician. Additionally, it's estimated that only a small proportion of adults with migraines in China receive proper clinical diagnoses. These statistics highlight a significant unmet need, further validating the significance of Lundbeck's application efforts in the region.
The SUNRISE Trial and Eptinezumab Efficacy
The submission to Japan includes a comprehensive clinical data package derived from the SUNRISE Phase 3 trial, recently published in the medical journal Cephalalgia. This trial demonstrates Vyepti's efficacy in reducing the frequency of migraine attacks. Notably, the safety profile of eptinezumab aligns closely with that of placebo, and the most common treatment-related adverse events reported included nasopharyngitis and COVID-19, underscoring its tolerability.
Lundbeck's Commitment to Migraine Treatment in Asia
Lundbeck is actively collaborating with regulatory authorities to expedite eptinezumab's availability across China, South Korea, and Japan. Having already gained approval in over 30 countries, Lundbeck is dedicated to enhancing brain health and meeting the pressing demands of individuals suffering from severe migraines.
Understanding Migraine: A Complex Challenge
Migraine is not merely a headache; it's a multifaceted neurological condition that affects a person's quality of life. It can bring debilitating symptoms including nausea, sensitivity to light and sound, and severe pain, which not only impairs daily functioning but also significantly impacts social interactions, family relationships, and professional productivity. The disease is recognized as one of the leading causes of disability for individuals under fifty, illustrating the urgent need for effective preventive therapies.
About the SUNRISE Trial's Design
The SUNRISE trial—verified as NCT04921384—was a randomized, double-blind, placebo-controlled study that aimed to confirm eptinezumab's efficacy for individuals experiencing chronic migraines in Asia. Participants in this trial exhibited chronic migraine characteristics, defined as experiencing headaches on eight or more days each month. Labeled an international study, it took place across numerous countries, showcasing Lundbeck's commitment to advancing global health.
About Vyepti and Its Market Potential
Vyepti (eptinezumab) is a humanized monoclonal antibody designed specifically for the intravenous treatment of migraine. Clinical trials have continually demonstrated its efficacy in both episodic and chronic migraine sufferers. The FDA approved eptinezumab for migraine prevention in adults in early 2020, and the European Commission followed suit in January 2022, recognizing its potential as a transformative therapeutic option. With launches in over 30 markets and growing, eptinezumab is poised to make a significant impact on the lives of migraine patients across Asia.
Frequently Asked Questions
What is Vyepti?
Vyepti is a monoclonal antibody designed for the preventive treatment of migraines, targeting calcitonin gene-related peptide (CGRP).
What regions are included in Lundbeck's recent applications?
Lundbeck has submitted applications for marketing authorization in Japan, China, and South Korea to enhance access to eptinezumab for migraine patients.
When was the SUNRISE trial conducted?
The SUNRISE trial was a Phase 3 clinical study assessing eptinezumab in Asian patients, conducted starting in May 2021.
What are the common adverse effects associated with eptinezumab?
The most common treatment-emergent adverse reactions observed during trials included nasopharyngitis and cases of COVID-19.
How does Lundbeck aim to expand its presence in Asia?
Lundbeck is working closely with regulatory authorities to expedite eptinezumab's availability and enhance treatment options for migraine patients throughout Asia.
