Shots:
- The Japanese MHLW has approved Vyepti (eptinezumab) for the prevention of migraine attacks in adults
- Approval was backed by extensive clinical data, incl. P-III (PROMISE-1, PROMISE-2 & DELIVER) studies as well as P-III (SUNRISE) trial, which assessed Vyepti in a predominantly Asian population; NDA was further supported by the SUNSET LTE trial conducted in Japanese pts
- Vyepti (IV) is a humanized mAb targeting CGRP for migraine prevention, with the approval marking Lundbeck’s first Japanese launch as Marketing Authorization Holder & enabling independent operations in Japan
Ref: PRnewswire | Image: Lundbeck | Press Release
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