RSV Antibody Approved in Europe and the U.K.

Following the European Commission's approval, the U.K. Medicines and Healthcare products Regulatory Agency recently approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

As of November 24, 2022, Nirsevimab is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

Nirsevimab is being developed jointly by Sanofi and AstraZeneca.

RSV is a common and highly contagious seasonal virus, infecting 90% of children by age two. It is also a leading cause of hospitalization in all infants.

The development of RSV vaccines began in the 1960s and has been identified as a priority for the World Health Organization Initiative for Vaccine Research.

The U.S. FDA is currently evaluating several RSV vaccine candidates but has not issued any approvals.