The US FDA has approved clesrovimab-cfor for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. This approval applies to those born during or entering their first RSV season. Clesrovimab-cfor is a long-acting monoclonal antibody, engineered to provide rapid and sustained protection for up to five months of the RSV season.
Clinical trial In clinical trials, clesrovimab-cfor significantly reduced the incidence of RSV-associated medically attended lower respiratory infections (MALRI) by 60.5% and RSV-associated hospitalizations by 84.3% in neonates and infants, compared to a placebo over 150 days. Furthermore, clesrovimab-cfor demonstrated comparable efficacy to palivizumab, a previously approved monoclonal antibody for RSV prevention. Dosage and administration Available as a single-dose prefilled syringe (105 mg/0.7 mL) for…