Shots:
- The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea
- The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO in 983 pts with chronic migraine for 36wks.; eligible Japanese pts continued treatment in the SUNSET trial with 60wks. of open-label eptinezumab & an 8Wk. safety follow-up
- SUNRISE showed superior efficacy of Vyepti in the prevention of migraine compared to PBO, with favorable safety; results were published in Cephalalgia
Ref: Lundbeck | Image: Lundbeck | Press Release
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