Sanofi/AstraZeneca’s Nirsevimab Is Set To Transform RSV Treatment In Infants

Sanofi executives discuss ongoing efforts to make the monoclonal antibody available for the next RSV season and the impact it will have as the first prophylactic treatment for all infants. An FDA advisory committee is expected to discuss the biologics license application at a yet-to-be announced meeting.

RSV infants
The biologics license application for the first RSV prophylaxis for all infants is under FDA review. • Source: Shutterstock

The decades long quest for a treatment to protect all infants from respiratory syncytial virus (RSV) infection is coming to fruition as Sanofi and AstraZeneca PLC’s monoclonal antibody nirsevimab is now under review at the US Food and Drug Administration. If approved, the product would be the first treatment to prevent RSV in all newborns and infants.

Swedish Orphan Biovitrum AB (Sobi)’s Synagis (palivizumab) has been the sole treatment option. However, it is indicated only for children at high risk of RSV disease, including those born prematurely and those with bronchopulmonary dysplasia or certain types of congenital heart disease

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