AstraZeneca, Sanofi win nod in China for RSV antibody Beyfortus
02 Jan 2024
Drug ApprovalVaccineClinical Study
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Source: FiercePharma
With an approval from the National Medical Products Administration (NMPA), AstraZeneca and Sanofi's Beyfortus has become the first RSV immunization to protect infants in China. The companies expect to launch it there in late 2024.
AstraZeneca and Sanofi have scored first in China with an approval for their respiratory syncytial virus (RSV) immunization Beyfortus for infants, with the companies expecting the shot to be available there for the 2024-25 season.
Beyfortus is the only immunization approved for babies entering their first RSV season to protect them against lower respiratory tract infection (LRTI). The antibody treatment can be given to all infants, regardless of health conditions or if they were born preterm.
Another option to prevent RSV in infants is Pfizer’s Abrysvo, which was approved in the U.S. and in Europe in August of last year. The shot can be used by mothers who have been pregnant for 32 to 36 weeks and affords protection for their babies over the first six months of their lives. Abrysvo has yet to be approved in China.
Over the last several months, many companies in Europe and the U.S. have turned to local partners in China to commercialize their products, including GSK, which has an agreement with Zhifei to market its shingles vaccine Shingrix, with the deal also expected to include its RSV shot Arexvy when it is approved in China.
China’s National Medical Products Administration (NMPA) signed off on Beyfortus based on three clinical trials. Across all clinical endpoints, Beyfortus demonstrated consistent efficacy against RSV lower respiratory tract disease (LRTD) extending through five months, the duration of a typical RSV season.
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