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MEDTECH Beyfortus is anticipated to be available for the upcoming RSV season in 2023–2024.
Beyfortus, a long-acting anti-RSV monoclonal antibody, has received FDA approval for its use in mitigating the risk of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants and toddlers. The approval came after extensive clinical trials demonstrating significant efficacy and tolerability in targeted patient groups.
Key Points:
- Beyfortus (nirsevimab-alip) has been granted FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants and toddlers aged up to 24 months.
- The drug is designed to be administered as a single dose aligned with the RSV season.
- Approval was based on data from three clinical trials, including phase 2b, phase 3 MELODY, and phase 2/3 MEDLEY trials.
Additional Points:
- The phase 2b trial reported a significant 70.1% reduction in medically-attended lower respiratory tract disease caused by RSV in infants who received Beyfortus.
- The MELODY trial demonstrated that Beyfortus is associated with a significant reduction in RSV-associated lower respiratory tract infections and hospitalizations.
- The MEDLEY trial indicated a comparable safety and tolerability profile for Beyfortus and palivizumab, a currently available RSV prevention option.
Conclusion:
- Despite some potential adverse reactions like rash and injection site reactions, Beyfortus represents a crucial advancement in infant health protection, especially during the RSV season.
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“Today’s approval marks an unprecedented moment for protecting infant health in the US, following an RSV season that took a record toll on infants, their families, and the US healthcare system.”
Thomas Triomphe
Executive Vice President, Vaccines
Sanofi
