US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) revealed that the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) voted to recommend Enflonsia (clesrovimab-cfor) as a preventive option for respiratory syncytial virus (RSV) lower respiratory tract disease in infants under 8 months of age at birth or entering their first RSV season. The committee also voted to include the drug in the Vaccines for Children (VFC) program.
Drug Profile
Enflonsia is a long-acting monoclonal antibody designed for passive immunization in newborns and infants. It aims to protect against RSV lower respiratory tract disease at birth or during their first RSV season.
Regulatory and Market Updates
Enflonsia received US approval earlier this month. MSD initially filed for marketing approval in China in April but withdrew the application a month later. This month, MSD resubmitted the filing, which was subsequently granted priority review status.-Fineline Info & Tech
