The Medical Letter on Drugs and Therapeutics
Nirsevimab (Beyfortus) for Prevention of Severe RSV Disease in Young Children
September 18, 2023 (Issue: 1685)The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering...more
- CDC. RSV surveillance & research. July 17, 2023. Available at: www.cdc.gov/rsv/research/index.html. Accessed August 29, 2023.
- C Rosas-Salazar et al. Respiratory syncytial virus infection during infancy and asthma during childhood in the USA (INSPIRE): a population-based, prospective birth cohort study. Lancet 2023; 401:1669. doi:10.1016/s0140-6736(23)00811-5
- S Hamid et al. Seasonality of respiratory syncytial virus ― United States, 2017-2023. MMWR Morb Mortal Wkly Rep 2023; 72:355. doi:10.15585/mmwr.mm7214a1
- MT Caserta et al. Palivizumab prophylaxis in infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2023; 152:e2023061803. doi:10.1542/peds.2023-061803
- B Kampmann et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023; 388:1451. doi:10.1056/nejmoa2216480
- MP Griffin et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med 2020; 383:415. doi:10.1056/nejmoa1913556
- LL Hammitt et al. Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med 2022; 386:837. doi:10.1056/nejmoa2110275
- WJ Muller et al. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med 2023; 388:1533. doi: 10.1056/nejmc2214773
- J Domachowske et al. Safety of nirsevimab for RSV in infants with heart or lung disease or prematurity. N Engl J Med 2022; 386:892. doi:10.1056/nejmc2112186
- S Drysdale et al. Efficacy of nirsevimab against RSV lower respiratory tract infection hospitalization in infants: preliminary data from the HARMONIE phase 3b trial. 41st Annual Meeting of the European Society for Paediatric Infectious Diseases; Lisbon & online; May 8-12, 2023. Abstract 1178. Available at: https://bit.ly/3YEyjjk. Accessed August 29, 2023.
- FDA Briefing Document. Nirsevimab. Antimicrobial Drugs Advisory Committee Meeting, June 8, 2023. Available at: https://www.fda.gov/media/169226/download. Accessed August 29, 2023.
- JM Jones et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morbid Mortal Wkly Rep 2023; 72:920. doi:10.15585/mmwr.mm7234a4
The Medical Letter is a subscriber-funded nonprofit organization that publishes critical appraisals of new prescription drugs and comparative reviews of drugs for common diseases.