On June 17, the CDE website showed that MSD's Clesrovimab(MK-1654)Marketing application for injectable solution proposed for priority review, with the indication beingUsed forAbout to enter or born in the first Respiratory Syncytial Virus（RSV）Prevention of RSV-Caused Lower Respiratory Tract Infections in Newborns and Infants During the Epidemic Season。Screenshot source: CDEOfficial WebsiteRSV is a contagious virus that can cause widespread seasonal infections. Clesrovimab is a preventiveLong-acting monoclonal antibody, which can induce passive immunity against RSV by binding to the fusion glycoprotein of RSV, thereby preventing RSV infection, aiming to provide direct, rapid, and long-lasting protection for infants.June 9,Clesrovimab Just received FDA approval in the United States,Is the first and only single-dose RSV monoclonal antibody for infants, regardless of the patient's weight.FDA Approval Based on 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,Evaluated the preterm infants and full-term infants(From Birth to 1 Year)Efficacy of a single dose of Clesrovimab injection. The trial met its primary and key secondary endpoints.
- Compared with placebo, on Day 150 after administration(5 months)，Clesrovimab Group Will Require Medical AttentionRSV-associated lower respiratory tract infections（MALRI）Incidence RateDecreased by 60.5%（95% CI：44.2, 72.0，p<0.001）, willRSV PhaseHospitalization RateDecreased by 84.3%（95% CI：66.7, 92.6，p<0.001） 。
- For infants entering the first epidemic season of RSV, the safety of Clesrovimab is roughly equivalent to that of placebo. The most common adverse reactions include injection site erythema occurring within 5 days after administration, injection site swelling occurring within 5 days after administration, and rash occurring within 14 days after administration.
SMART Study is a randomized, partially blinded, multi-center Phase III clinical trial designed to evaluateClesrovimab Head-to-HeadPalivizumabInSafety and Efficacy in High-Risk Infants with Severe RSV Infection.
SMART The trial results showed that the incidence rates of RSV-related MALRI and RSV-related hospitalization were comparable between Clesrovimab and Palivizumab.The safety profile was also generally comparable to palivizumab and consistent with the CLEVER trial.Clesrovimab Consistent safety in infants.Insight database shows,Three RSV Monoclonal Antibodies Have Been Approved for Marketing Worldwide, respectively AstraZeneca/SanofiFei'sNirsevimab, AstraZeneca/Sobi PharmaceuticalsPalivizumab,MSD'sClesrovimab。In China, currently onlyAstraZeneca/SanofiFei'sNirsevimab Approved.MSD'sClesrovimab has been reported to be on the market.In addition, two RSV monoclonal antibodies have entered Phase III clinical trials, respectively fromTainuo Maibo（TNM001）, Ruiyang Bio（RB0026）。Screenshot source: Insight databaseScan the QR code below to add「"Little Sound", reply with the commandNew Drug Application for Market Launch, you can obtain Insight's comprehensive resource package on global new drug applications and market approvals for January to May 2025.'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
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