US Edition
FDA Approves Merck’s Enflonsia to Prevent RSV in Infants
- The FDA approved Merck's monoclonal antibody clesrovimab, marketed as Enflonsia, on Monday to protect infants under 12 months from RSV.
- This approval follows nearly three decades of Synagis being the sole FDA-approved product for RSV protection in infants and a recent surge in RSV preventive treatments.
- Enflonsia showed a 60% reduction in RSV infections and over 84% fewer hospitalizations during clinical trials, offering dosing convenience as a single shot regardless of infant weight.
- Merck aims to supply Enflonsia in time for the 2025 RSV season with a wholesale price of $556 per dose, matching Sanofi's Beyfortus, which generated $1.6 billion revenue in 2024.
- The approval introduces competition to existing products but coincides with the firing of the 17 ACIP members, raising concerns about vaccine guidance and potential delays in recommendations.
60 Articles
60 Articles
FDA Approves New RSV Antibody For Infants — Here’s What To Know
Pollyana Ventura/E+/Getty ImagesOn June 9, the Food and Drug administration (FDA) approved Enflonsia, a new preventative antibody shot to protect infants up to 1 year old from RSV, a viral infection of the respiratory tract and the number one cause of hospitalization in infants. Drug maker Merck says they are committed to ensuring availability of Enflonsia before the start of the upcoming RSV season.RSV in infants is characterized by cold-like s…
FDA Approves RSV Shot For Infants - DISTURBING Serious Adverse Event Rate In Clinical Trials * 100PercentFedUp.com * by Danielle
Merck's newly approved RSV shot for infants raises serious concerns, with clinical trials revealing an alarming 11.71% rate of adverse events, including seizures and brain injury. What does this mean for our children’s health? Dive deeper into the findings.
Grand Rapids Herald-Review
New Antibody Shot Could Help Protect Babies From RSV
Key Takeaways
FDA Approves Merck’s Enflonsia to prevent RSV in infants
The Food and Drug Administration has approved a new drug from Merck designed to protect infants from respiratory syncytial virus, or RSV, a common but potentially serious seasonal illness.The drug, Enflonsia, is a long-acting monoclonal antibody intended to prevent RSV-related lower respiratory tract disease in newborns and infants entering their first RSV season.RSV is a leading cause of hospitalization among infants in the United States, espec…
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