Nirsevimab significantly protected infants against RSV disease in Phase III

Detailed results from the positive MELODY Phase III trial showed a single dose of nirsevimab met the primary efficacy endpoint reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) by 74.5% (95% CI 49.6, 87.1; p<0.001), compared to placebo, in healthy term and late preterm (gestational age ≥35 weeks) infants entering their first RSV season.

Nirsevimab is being developed by UK-based AstraZeneca (LSE: AZN) in collaboration with French pharma major Sanofi (Euronext: SAN) and just last month was accepted for accelerated assessment by the European Medicines Agency.

Additionally, the MEDLEY Phase II/III trial, which evaluated safety and pharmacokinetics of nirsevimab in infants with congenital heart disease (CHD), chronic lung disease (CLD) and prematurity entering their first RSV season, demonstrated nirsevimab had a similar safety and tolerability profile compared to Synagis (palivizumab), from Swedish Orphan Biovitrum (STO: SOBI) but licensed to AstraZeneca ex-USA, and also the current market sector leader.