RSV prevention infant monoclonal antibody FDA approval with respiratory syncytial virus protection
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Merck Receives FDA Approval for Clesrovimab for RSV Prevention in Infants

Merck announces FDA approval of clesrovimab (Beyfortus) as a single-dose monoclonal antibody for the prevention of RSV disease in infants.

Merck today announced that the FDA has approved clesrovimab (Beyfortus) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants. Clesrovimab is a long-acting monoclonal antibody that demonstrated 79% efficacy in preventing medically attended RSV lower respiratory tract infection in the Phase 2/3 MELODY trial. The single-dose administration at birth or at the start of RSV season provides convenient protection for infants during their first RSV season. This approval provides a new option for RSV prevention in infants alongside existing immunoprophylaxis options.

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