MSD has announced that Singapore’s Health Sciences Authority (HSA) has approved ENFLONSIA™ (clesrovimab) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering their first RSV season. This makes Singapore the first market in the Asia Pacific region to approve this treatment.
ENFLONSIA™ is a long-acting monoclonal antibody designed to offer protection for five to six months with a consistent 105mg dose, irrespective of the infant’s weight. This approval provides an additional preventive option for infants during the critical RSV season, which in Singapore peaks from May to September.
Assistant Professor Yeo Kee Thai from KK Women’s and Children’s Hospital highlighted the importance of such developments, stating, “Infections from RSV can result in serious respiratory conditions in young children, including bronchiolitis and pneumonia.” Dr Jenny Tang from SBCC Baby & Child Clinic emphasised the global significance of RSV as a cause of hospitalisation in infants, noting its association with long-term respiratory issues.
The approval is based on the results from the Phase 2b/3 CLEVER trial and the Phase 3 SMART trial, which evaluated the safety and efficacy of ENFLONSIA™. Dr Ivan Su from MSD Asia Pacific expressed satisfaction with the approval, noting the treatment’s role in reducing the burden of RSV on families and healthcare systems.
ENFLONSIA™ is now available for administration by healthcare providers in Singapore, marking a significant step in the nation’s preventive healthcare efforts.
