The FDA recently approved a new therapy, Enflonsia (clesrovimab-cfor) from Merck & CO., indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia is a F protein-directed fusion inhibitor.
Enflonsia is currently the only RSV preventive approved at a fixed dose (105-mg) regardless of infant weight, which may simplify administration, and provides protection for 5 months—the length of a typical RSV season.
As noted in the article, “RSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious respiratory conditions like bronchiolitis and pneumonia.” Further, “Merck reported that Enflonsia reduced hospitalizations due to RSV-associated lower respiratory tract infections by more than 90%.”
RSV is responsible for between 58,000 and 80,000 hospitalizations of young children and between 60,000 and 160,000 hospitalizations of seniors in an average year, the bulk of which happen in the fall and winter. These are estimated to result in between 6,000 and 10,000 deaths among seniors and 100–300 deaths among children younger than 5 annually.
The wholesale price for Enflonsia 105mg has been set at $556 a dose, Merck said, which is the same price charged for its major competitor, Sanofi and AstraZeneca’s Beyfortus (nirsevimab).
The company did not release any details related to distribution.
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FDA Approves Clesrovimab to Prevent RSV in Infants During First Season
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