AstraZeneca's Nirsevimab Shows Favorable Safety, Tolerability Profile In Infants At High Risk Of RSV

AstraZeneca Plc AZN announced data from the MEDLEY Phase 2/3 trial evaluating nirsevimab in infants at high risk of respiratory syncytial virus (RSV).
The trial assessed the safety and tolerability of nirsevimab compared to Sobi's Synagis (palivizumab) in infants with chronic lung disease, congenital heart disease, and/or prematurity.
RSV is a common, contagious pathogen that causes seasonal epidemics of lower respiratory tract infections (LRTI), including bronchiolitis and pneumonia.
Nirsevimab, being developed by AstraZeneca and Sanofi SA SNY, showed a safety and tolerability profile comparable to the only available preventative option against lower respiratory tract infections (LRTI) caused by RSV, with one dose for the entire season.
The occurrence of treatment-emergent adverse events or treatment-emergent serious adverse events was similar between groups.
Full results from the MEDLEY trial will be presented at a forthcoming medical meeting. The trial is ongoing to collect additional safety data.
Nirsevimab is also being evaluated in the MELODY Phase 3 trial, which met its primary endpoint of a statistically significant reduction in the incidence of medically attended LRTI caused by RSV compared to placebo healthy late preterm and term infants.
The company plans regulatory submissions from the first half of 2022.
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