RSV Monoclonal Antibody Availability Simplified

Sanofi today announced in a press release it had simplified its contractual arrangements relating to the development and commercialization of Beyfortus® (nirsevimab) in the United States (U.S.).

As of April 11, 2023, Beyfortus is an investigational long-acting antibody designed to protect all infants against Respiratory Syncytial Virus (RSV) infections from birth through their first RSV viral season with a single dose.

Under the new and updated arrangements, Sanofi has complete commercial control of Beyfortus in the U.S.

Concerning territories outside the U.S., the existing Collaboration Agreement between AstraZeneca and Sanofi continues to govern that relationship.

The new and updated contractual agreements do not impact Beyfortus registration and launch in the U.S., where all parties remain committed to making Beyfortus available for all infants in time for the 2023/24 RSV season.

Beyfortus is a monoclonal antibody (mAbs) that does not require immune system activation to confer direct and rapid protection against infection.

Beyfortus has already received marketing authorization in the European Union to prevent lower respiratory tract disease caused by RSV in neonates and infants from birth during their first RSV season.

This RSV mAbs pending approval in the U.S. is independent of the Food and Drug Administration's efforts to authorize RSV vaccines in 2023.