H. Lundbeck A/S has received marketing authorisation from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vyepti (eptinezumab) as a preventive treatment for migraine in adults.
- Clinical basis: The approval was supported by data from multiple Phase 3 studies, including the SUNRISE trial conducted in a predominantly Asian population with chronic migraine.
- Mechanism and route: Eptinezumab is an anti-calcitonin gene-related peptide (CGRP) humanised monoclonal antibody developed for intravenous administration.
- Target indication: Intended for the preventive treatment of migraine in adults experiencing recurrent migraine attacks.
This summary is based on a press release issued by H. Lundbeck A/S via PR Newswire.
Image for illustrative purposes only. Source: Canva.
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