Sanofi Submits New Application for Long-Acting RSV Antibody Treatment

Stock News08-07

On August 7, the CDE website announced that an application for a new indication for Sanofi SA (SNY.US)'s nirsevimab injection has been accepted, classified as Category 3.1.

According to public information and clinical trial progress, Insight Database speculates that the submitted indication is for preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in infants: specifically, newborns and infants who are about to enter or are born during their second RSV season.

Nirsevimab is a single-dose, long-acting antibody vaccine developed jointly by Sanofi SA and AstraZeneca. It requires only one dose to provide rapid protection through antibodies, helping prevent lower respiratory tract diseases caused by RSV without needing to activate the immune system.

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