AstraZeneca: Beyfortus approved in Japan

(CercleFinance.com) - AstraZeneca reports that AstraZeneca and Sanofi's Beyfortus (nirsevimab) has been approved in Japan for the prophylaxis of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in all newborns, infants and children entering their first RSV.


Beyfortus is expected to be available for the upcoming RSV 2024/25 season, in line with existing Japanese guidelines.

The Japanese Ministry of Health, Labor and Welfare's approval is based on three late-stage pivotal clinical trials of Beyfortus, which showed that a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD extending over five months, the duration of a typical RSV season.


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