H. Lundbeck A/S has received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vyepti (eptinezumab; ALD403) for the preventive treatment of migraine in adults, extending the drug’s reach into Asia following approvals in the US and EU. The authorization adds South Korea to a list of more than 30 markets where eptinezumab is now available.
Eptinezumab is administered intravenously, a delivery route that distinguishes it from the subcutaneous CGRP monoclonal antibodies in the same class. The MFDS authorization covers the preventive treatment of migraine in adults broadly, without a stated restriction to episodic or chronic migraine subtypes. The approval was supported by results from four Phase III trials: PROMISE-1, PROMISE-2, DELIVER, and SUNRISE, the last of which was conducted in a predominantly Asian population with chronic migraine and served as the confirmatory basis for the South Korean submission.
The SUNRISE trial was a randomized, placebo-controlled Phase III study enrolling patients with chronic migraine drawn predominantly from Asian countries. The primary endpoint was reduction in monthly migraine days over the treatment period. Supporting data from PROMISE-1 and PROMISE-2, which enrolled episodic and chronic migraine populations respectively, demonstrated that eptinezumab met its primary endpoint of reducing monthly migraine days over weeks 1–12 at both the 100 mg and 300 mg doses. A treatment benefit over placebo was observed as early as day one post-infusion in both trials. The safety evaluation across more than 2,000 adults identified nasopharyngitis and hypersensitivity as the most common adverse reactions, with 1.9% of patients discontinuing due to adverse events in PROMISE-1 and PROMISE-2.
Mechanism and platform context
Eptinezumab is a humanized monoclonal antibody that neutralizes the calcitonin gene-related peptide (CGRP) ligand, blocking downstream receptor activation implicated in migraine pathophysiology. Its IV formulation was an intentional design choice, enabling rapid onset of action — reflected in the day-one efficacy signal observed in the PROMISE trials. This ligand-targeting approach places eptinezumab in the same mechanistic subclass as fremanezumab (Ajovy, Teva Pharmaceutical Industries), which also binds the CGRP peptide rather than its receptor.