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Nirsevimab-alip

(Beyfortus®)

Nirsevimab-alip

Drug updated on 10/21/2024

Dosage FormInjection (intramuscular; 50 mg/0.5 mL [100mg/ml])
Drug ClassRespiratory syncytial virus (RSV) F protein-directed fusion inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season
  • Indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Nirsevimab demonstrated a pooled immunization efficacy of 88.40% in preventing hospital admissions due to Respiratory Syncytial Virus (RSV) among infants, with a relative risk reduction (RR) of 0.24 (95% Confidence Interval (CI): 0.13-0.47), as reported in a random-effects meta-analysis.
  • Nirsevimab significantly reduced the risk of medically attended RSV-related infections, showing a risk reduction of 0.26 (95% CI: 0.18-0.38), and prevented RSV-related infections by 123 cases per 1000 participants (95% CI: -138 to -100).
  • In terms of preventing medically attended RSV lower respiratory tract infections (LRTI), nirsevimab demonstrated a 79.5% relative risk reduction compared to placebo.
  • There was no significant difference in adverse events leading to death (RR: 0.78, 95% CI: 0.20-2.98) or adverse events of special interest (RR: 0.92, 95% CI: 0.25-3.38) associated with nirsevimab.
  • No significant differences in drug-related adverse events were observed when compared to other treatments, according to a network meta-analysis.
  • The studies included infants and newborns, with specific subgroups such as high-risk infants (e.g., those with chronic lung disease, congenital heart disease, or extreme prematurity). Nirsevimab was found to have serum exposures above the target in over 80% of the MEDLEY trial population, supporting its use in these subgroups.