Lundbeck’s Vyepti wins MFDS approval in South Korea, expanding access to preventive migraine therapy with rapid IV delivery and robust Phase 3 data.
By: Regulatory Desk
Lundbeck A/S has received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vyepti (eptinezumab) in adults with migraine. The decision expands the therapy’s reach to more than 30 global markets, reinforcing Lundbeck’s strategy to broaden access to preventive migraine treatments worldwide.
Clinical Evidence
The MFDS approval was supported by four Phase 3 studies: PROMISE‑1 (episodic migraine), PROMISE‑2 (chronic migraine), DELIVER, and SUNRISE. Across trials, eptinezumab significantly reduced monthly migraine days over the first 12 weeks compared with placebo. Benefits were observed as early as Day 1 post‑infusion for both 100 mg and 300 mg doses.
Regional Relevance
The SUNRISE study carried strategic importance by enrolling a predominantly Asian chronic migraine population. Results confirmed efficacy and safety in regional patient groups, strengthening Lundbeck’s expansion across Asia‑Pacific markets.
Safety Profile
Safety findings remained consistent with earlier data. The most common adverse events included nasopharyngitis and hypersensitivity reactions. In the pivotal PROMISE trials, 1.9% of patients discontinued therapy due to adverse events.
Mechanism of Action
Eptinezumab is a humanized monoclonal antibody that neutralizes calcitonin gene‑related peptide (CGRP), a central mediator in migraine pathophysiology. Unlike subcutaneous CGRP inhibitors such as erenumab or fremanezumab, Vyepti is administered via intravenous infusion, enabling rapid systemic exposure and early onset of effect.
Executive Commentary
Johan Luthman, Executive Vice President and Head of Research and Development at Lundbeck, said: “This approval marks an important milestone for people living with migraine in Korea, many of whom remain underserved by existing preventive options.”
Global Positioning
Vyepti first gained U.S. FDA approval in 2020 for migraine prevention in adults, followed by European Commission authorization in 2022 for patients experiencing at least four migraine days per month. The South Korea approval underscores Lundbeck’s commitment to expanding commercial access and addressing unmet needs in migraine prevention across international markets.
Disease Burden
Migraine is among the leading causes of disability globally and the top cause of disability in people under 50. In South Korea, the condition affects an estimated 11% of the population, though experts believe the true burden is higher due to underdiagnosis and limited uptake of preventive therapies.
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