H. Lundbeck A/S announced the acceptance of its new drug application (NDA) for Vyepti (eptinezumab) by Japan's Ministry of Health, Labor and Welfare (MHLW), alongside similar marketing authorization applications in China and South Korea. The submissions represent a significant expansion of the Danish biopharmaceutical company's migraine prevention therapy into key Asian markets, where preventive treatments remain significantly underutilized.
Addressing Critical Unmet Need in Asian Markets
Despite migraine prevalence in Asia matching Western countries, substantial gaps exist in diagnosis and treatment access across the region. In Japan, 59.4% to 71.8% of individuals with migraine have never consulted a physician, while in Korea this figure reaches approximately 75.6%. The situation is particularly acute in China, where only 13.8% of adults living with migraine receive clinical diagnosis.
"Eptinezumab has the potential to fulfil a significant unmet need in Asia, where migraine preventive treatments remain underutilized," said Johan Luthman, EVP and Head of Research and Development at Lundbeck. "The eptinezumab global roll-out also paves the way for advancing additional migraine and neuro-rare programs to patients."
SUNRISE Trial Supports Asian Expansion
The regulatory submissions are backed by robust clinical data from the SUNRISE Phase 3 registrational trial, recently published in Cephalalgia. This interventional, multi-regional, randomized, double-blind, placebo-controlled study specifically evaluated eptinezumab's efficacy and safety in a predominantly Asian population with chronic migraine.
The trial enrolled 983 participants across Mainland China, Georgia, Japan, Poland, Slovakia, South Korea, Spain and Taiwan, who were randomized to receive eptinezumab 100 mg, 300 mg, or placebo by intravenous infusion. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days.
Results demonstrated eptinezumab's efficacy in preventing migraine, with a safety profile generally similar to placebo and consistent with previous trials. The most common treatment-emergent adverse events were COVID-19 and nasopharyngitis.
Mechanism and Clinical Profile
Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), intentionally designed for intravenous administration. The therapy's efficacy was previously established in two Phase 3 clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where it met primary endpoints of decreased monthly migraine days over weeks 1-12 in both patient populations.
Clinical trial data demonstrated treatment benefits over placebo for both 100 mg and 300 mg doses as early as Day 1 post-infusion. Safety evaluation in more than 2,000 adult patients showed the most common adverse reactions (≥2% and at least 2% greater than placebo) were nasopharyngitis and hypersensitivity, with 1.9% of patients discontinuing treatment due to adverse reactions.
Global Market Presence and Strategic Impact
VYEPTI received FDA approval for migraine prevention in adults in February 2020, followed by European Commission marketing authorization in January 2022 for prophylaxis in adults with at least four migraine days per month. The therapy is currently launched in more than 30 markets worldwide.
If approved, these Asian applications would mark Lundbeck's first marketing authorization in Japan and the first biologic launch by the company in China and South Korea. The submissions align with Lundbeck's Focused Innovator strategy, extending operational capabilities in Asia while demonstrating leadership in the migraine treatment space.
Disease Burden and Treatment Landscape
Migraine represents one of the most prevalent neurological diseases requiring medical treatment, ranking as the leading cause of disability for people under age 50 and the second leading cause of disability worldwide. The complex neurological condition is characterized by recurrent severe headaches accompanied by nausea, vomiting, and sensitivity to light or sound, imposing substantial social and financial burdens on patients and healthcare systems.
The condition profoundly impacts patient functioning, affecting relationships, leisure activities, household productivity, and work performance. Without proper preventive management, increased use of acute headache medications can lead to central sensitization and decreased effectiveness, creating a cycle of worsening symptoms and chronification.
