On December 17, MSD announced, Clesrovimab(MK-1654)Biologics License Application(BLA)Accepted by the U.S. FDA forPrevention of Infant Respiratory Syncytial DiseaseToxic（RSV）Infection. If approved, this will beThe First and Only Single-Dose RSV Monoclonal Antibody for Infants, regardless of weight. The PDUFA date is June 10, 2025.Clesrovimab is an investigationalLong-acting monoclonal antibody, by binding to the fusion glycoprotein of RSV to induce passive immunity against RSV, thereby preventing RSV infection.The marketing application is based on the pivotal Phase IIb/III CLEVER study.（MK-1654-004 ）and Phase III SMART Study（MK-1654-007）Results.CLEVER Study is a randomized, double-blind, placebo-controlledPhase IIb/IIIClinical trial to evaluate the efficacy and safety of Clesrovimab in healthy preterm and term infants entering their first RSV season. The study enrolled a total of3,632 namesSubjects were randomly assigned in a 2:1 ratio to receive a single fixed dose of Clesrovimab and placebo.The results showed that, compared with the placebo, on the 150th day after administration(5 months)Incidence of RSV-associated Lower Respiratory Tract Infections (MALRI)Decreased by 60.4%（95% CI：44.1, 71.9，p<0.001）. RSV-related hospitalization rate and RSV-related lower respiratory tract infection (LRI) hospitalization rate, respectivelyDecreased by 84.2%（95% CI：66.6, 92.6，p<0.001） And 90.9%（95% CI：76.2, 96.5）。
SMART Study is a randomized, partially blinded, multi-center Phase III clinical trial designed to evaluateClesrovimab Head-to-Head PembrolizumabSafety, efficacy, and pharmacokinetics in infants and children at high risk for severe RSV disease, with a total enrollment of901 subjectsPatient。Interim results show that the safety of Clesrovimab is comparable to Palivizumab, and no serious drug-related adverse reactions have been reported to date. As of Day 150(5 months)The incidence of RSV-related MALRI and RSV-related hospitalization rates for Clesrovimab and Palivizumab were also comparable.
Respiratory Syncytial Virus (RSV) is a contagious virus that causes a wide range of seasonal infections, similar to the flu, affecting infants, young children, and the elderly worldwide. The preventive needs for both healthy and high-risk infants remain unmet. Globally, RSV is the leading cause of hospitalization for healthy infants under one year of age and a major cause of infant mortality in low- and middle-income countries. RSV can lead to severe respiratory diseases such as bronchiolitis and pneumonia, resulting in approximately 3.6 million hospitalizations and 101,000 deaths annually worldwide.Cover Source:Corporate Logo
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