Breakthrough therapy designation of nirsevimab for the prevention of lower respiratory tract illness caused by respiratory syncytial virus infections (RSV).

Nirsevimab (MEDI8897) is an RSV F protein monoclonal antibody and the next-generation RSV medicine having an extended half-life developed for the prevention of LRTI caused by RSV. Nirsevimab will supplant the current standard of care for RSV prevention. Importantly, nirsevimab requires a single dose to last the entire RSV season and may be given to term, preterm, and high-risk infants. However, even with nirsevimab approval there remains a need for an efficacious RSV vaccine and treatments.