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Nirsevimab significantly protected infants against RSV disease in Phase 3 trial Nirsevimab showed a 74.5% reduction in lower respiratory tract infections caused by RSV requiring medical care in healthy infants1,2Nirsevimab is the first investigational immunization designed to protect all infants across th...
and tolerability profile in infants at high risk of RSV The MEDLEY Phase II/III trial evaluated the safety and tolerability of nirsevimab compared to Synagis (palivizumab) when given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season. 1 The trial assessed the safety of nirsevimab in infants with chronic lung disease (CLD), congenital heart disease (CHD) and/or prematurity. Occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) were sim...
Sanofi: MHRA Grants Promising Innovative Medicine Designation to Nirsevimab 1,2 RSV is a contagious virus, and the most common cause of severe lower respiratory tract infections (LRTI) in infants and young children, resulting in over 30,000 hospitalisations per year in the UK due to RSV-associated LRTIs for children under five years 3 Promising Innovative Medicine (PIM) Designation was granted based on non-clinical and clinical data of nirsevimab in healthy preterm infants Nirsevimab does not have a Marketing Authorisation (MA) in the UK for any indication FOR MEDICAL AND PHARMACEUTICAL TRADE...