(ANSA) - ROME, MAY 12 - New data further consolidate the efficacy profile of the monoclonal antibody nirsevimab on respiratory syncytial virus (RSV), which in infants and children in the first years of life is the most common cause of lower respiratory tract infections, such as bronchiolitis and pneumonia.
Furthermore, RSV is also a leading cause of hospitalizations for newborns, most of which occur in healthy full-term babies.
Nirsevimab has been shown to be 79.5% effective against medical care-requiring lower respiratory tract infections, such as bronchiolitis or pneumonia, caused by Rsv in full-term or preterm infants entering their first season of respiratory syncytial virus.
The efficacy demonstrated is the relative risk reduction compared to placebo and derives from an analysis of the results of the pivotal studies of phase 3 MELODY and phase 2b (prespecified pooled analysis).
Blood samples from infants administered nirsevimab have 50 times more RSV neutralizing antibodies on day 151 (5 months later) than the concentrations present prior to the administration of a dose.
"The RSV remains the most common cause of lower respiratory tract infections in newborns and causes seasonal epidemics worldwide every year, explains Eric Simões, of UC Denver School of Medicine. These new analyzes reinforce the potential of nirsevimab in protecting all newborns during it. respiratory syncytial virus season with a single dose, which could lead to a paradigm shift in virus prevention itself. "
Nirsevimab is developed by Sanofi and AstraZeneca: it is an experimental long-acting monoclonal antibody designed to protect, with a single dose, fixed dose and pre-filled syringe, all infants in their first season of Rsv.
Safety and
dinirsevimab efficacy are currently being evaluated with an accelerated procedure by EMA, the European Medicines Agency.
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