On July 18, AstraZeneca announced that Beyfortus (Nirsevimab nisibizumab), co-developed by AstraZeneca and Sanofi, was approved in the U.S. for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in infants and children. The drug is indicated for newborns and infants born during or entering the first RSV epidemic season, and for infants and children younger than 24 months of age who remain susceptible to severe RSV disease during the second RSV epidemic season. The drug will be available in the US by the 2023-2024 RSV epidemic season.
The U.S. Food and Drug Administration's (FDA) approval of Nirsevimab was reportedly preceded by a vote of the Antimicrobial Medicines Advisory Committee (AMDAC) on a favorable benefit-risk analysis of Nirsevimab, which resulted in a unanimous vote, and was based on the successful clinical development of Nirsevimab, including the results of three pivotal late-stage clinical studies. For all trial endpoints, a single dose of Nirsevimab demonstrated consistent efficacy against lower respiratory tract disease caused by respiratory syncytial virus infection for five months, the duration of a typical RSV epidemic season.
Nirsevimab is the first prevention regimen approved to protect the entire infant and child population, including those who are healthy term infants, preterm infants, or infants predisposed to severe RSV disease due to a specific health condition.The timing of a single dose of Nirsevimab is flexible, and can be administered at the beginning of the RSV epidemic season, or at the time of birth of infants.
In the United States, RSV is the leading cause of hospitalization in U.S. infants under the age of 1 year, averaging 16 times the annual incidence of influenza. Each year in the United States, approximately 590,000 cases of RSV infection in infants under 1 year of age require medical intervention, including outpatient visits, urgent care, emergency room visits and hospitalization.
Nirsevimab was generally well tolerated and had a favorable safety profile in all clinical trials.The overall incidence of adverse events was comparable between Nirsevimab and placebo, with the majority of adverse events being mild or moderate in severity. The most common adverse events were rash and injection site reactions.
Nirsevimab was approved in the European Union in October 2022 to help prevent RSV-induced lower respiratory tract disease in newborns and infants during the first RSV epidemic season. Marketing applications for Nirsevimab submitted in China, Japan and several other countries are currently under review.
About Nirsevimab
Nirsevimab is a single-dose, sub-long-acting antibody co-developed and commercialized by AstraZeneca and Sanofi using AstraZeneca's YTE technology. The drug is designed to protect newborns and infants born during or entering the first RSV epidemic season, and infants and young children up to 24 months of age who remain susceptible to severe RSV disease during the second RSV epidemic season.The Nirsevimab antibody provides newborns and young infants with prompt, rapid protection against lower respiratory tract disease caused by RSV in a single dose without the need to activate the immune system. Nirsevimab can be administered at the beginning of the RSV season.
Nirsevimab has received relevant accreditations from several key regulatory agencies around the world to accelerate its clinical development, including Breakthrough Therapy Accreditation and Priority Review status by the Drug Review Center under the State Drug Administration (NMPA) of China, Breakthrough Therapy Accreditation by the U.S. FDA, Priority Medicines Eligibility (PRIME) by the European Medicines Agency (EMA), and Priority Medicines Eligibility (PME) by the Japanese Agency for the Control of Medicinal Products (ACAP). (PRIME) by the European Medicines Agency (EMA), and "Priority Drugs for Development" in the "Drug Selection Research Program for Pediatric Drug Development" by the Japan Agency for Medical Research and Development (AMED).
