Partners Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) have announced that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of Leqembi (lecanemab)—which was accepted last month—has been designated for Priority Review by the National Medical Products Administration (NMPA) of China.
Leqembi is an anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease (AD).
China’s priority review and approval procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.
https://www.thepharmaletter.com/sc-leqembi-lands-priority-review-in-china
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