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

INTRODUCTION: Respiratory syncytial virus (RSV) is a leading cause of serious lower respiratory tract infection (LRTI) in infants and young children. Palivizumab is an RSV-specific prophylactic for use in high-risk infants but treatment requires monthly injections and only modestly reduces hospitalization. Thus, new immunoprophylactic candidates are under development. Nirsevimab (MEDI8897) is a monoclonal antibody with an extended half-life developed to protect infants for an entire RSV season with a single dose. AREAS COVERED: This review summarizes clinical trial data on nirsevimab. The authors introduce RSV and surface viral proteins involved in infection, then discuss the development and achievements of nirsevimab in clinical trials concluding with expert opinion. Information was compiled from PubMed, clinicaltrials.gov, and press releases from AstraZeneca and Sanofi. EXPERT OPINION: 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.