NIRSEVIMAB has been approved by the US FDA as the first RSV prevention measure for all infant populations

The US Food and Drug Administration (FDA) has announced the approval of a monoclonal antibody nirsevimab for the prevention of respiratory syncytial virus (RSV) related lower respiratory diseases in all infant populations.The FDA approves nirsevimab for the prevention of lower respiratory tract diseases caused by RSV in infants and young children: newborns and infants who are about to enter or are born during the first RSV infection season, as well as children who are still susceptible to severe RSV diseases within 24 months of age during the second RSV infection season

The US Food and Drug Administration (FDA) has announced the approval of a monoclonal antibody nirsevimab for the prevention of respiratory syncytial virus (RSV) related lower respiratory diseases in all infant populations.

The FDA approves nirsevimab for the prevention of lower respiratory tract diseases caused by RSV in infants and young children: newborns and infants who are about to enter or are born during the first RSV infection season, as well as children who are still susceptible to severe RSV diseases within 24 months of age during the second RSV infection season. Nirsevimab was jointly developed by Sanofi and AstraZeneca.

In October 2022, Nirsevimab received its first global approval in the European Union. In China, nirsevimab has also won the breakthrough Sex therapy drug procedure and priority review qualification granted by the Drug Evaluation Center (CDE) of the National Medical Products Administration, and is expected to be approved in China as soon as possible, providing long-term protection for Chinese infants.

Nirsevimab's FDA approval is based on the results of multiple clinical trials, including three key post clinical trials (Phase 2b trial, Phase 3 MELODY trial, and Phase 2/3 MEDLEY trial). Phase 2b trial is a randomized, placebo-controlled trial to evaluate the protective effect of nirsevimab injection on RSV induced Lower respiratory tract infection (RSVLRTI) in healthy preterm infants within 29 to 35 weeks of gestational age within 150 days. Infants were randomly assigned to receive a single injection of nirsevimab or placebo. The primary endpoint results showed that nirsevimab significantly reduced the RSVLRTI visit rate by 70.1% compared to placebo, while demonstrating good safety.

Xinmin Evening News reporter Zuo Yan

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