FDA Approves Breakthrough RSV Drug to Safeguard Infants and Toddlers

The FDA has approved Beyfortus (nirsevimab-alip), a new drug developed by AstraZeneca, for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age. RSV can cause serious respiratory infections in infants and young children, leading to hospitalizations. Beyfortus is a monoclonal antibody that provides protection against RSV when administered as a single intramuscular injection prior to or during RSV season. Clinical trials showed that Beyfortus reduced the risk of medically attended RSV lower respiratory tract infection by approximately 70% to 75% compared to placebo. Possible side effects include rash and injection site reactions.
- FDA Approves New Drug to Prevent RSV in Babies and Toddlers FDA.gov
- FDA approves antibody to protect infants from RSV CNN
- FDA approves AstraZeneca, Sanofi shot that protects infants and toddlers against RSV CNBC
- FDA Approves First RSV Drug to Protect All Infants From Virus The Wall Street Journal
- FDA approves RSV monoclonal antibody for infants, young children at high risk STAT
- View Full Coverage on Google News
Reading Insights
0
1
4 min
vs 5 min read
87%
824 → 105 words
Want the full story? Read the original article
Read on FDA.gov