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AstraZeneca’s Beyfortus approved in the EU

AstraZeneca and Sanofi’s Beyfortus has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

“The European Commission is the first regulatory body to grant approval to Beyfortus.”

The European Commission is the first regulatory body to grant approval to Beyfortus.

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The approval was based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials, and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2022.

Photo: AstraZeneca R&D

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