Acip Recommends Use of Merck's Enflonsia for Prevention of Respiratory Syncytial Virus
MRK
Published on 06/26/2025 at 15:20
Merck announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ENFLONSIA?? (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season. The ACIP also voted to include ENFLONSIA in the Vaccines for Children Program--an important step in ensuring broad access to this preventive option for infants.
ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of weight. The U.S. Food and Drug Administration (FDA) approved ENFLONSIA earlier this month based on clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck plans to make ENFLONSIA available for ordering by physicians and health care administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season.
The AC IP's recommendation for ENFLONSIA is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director). ENFLONSIA is Merck's extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory synCytial virus (RSV") lower respiratory tract disease in newborns and infants who are born during or entering its first RSV season. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. R risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
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