New data show nirsevimab delivers 83% reduction in RSV infant hospitalizations

12 May 2023
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French pharma major Sanofi (Euronext: SAN) edged up 1% on release of new data that adds to the body of evidence demonstrating nirsevimab’s protection against respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) and confirm its favorable safety profile in multi-country, real-world conditions

Results from the HARMONIE Phase IIIb clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001 reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention.

The magnitude of nirsevimab’s hospitalization reduction comes in well ahead of Swedish Orphan Biovitrum’s (STO: SOBI) Synagis (palivizumab), the only Food and Drug Administration-approved RSV antibody. Synagis, which won FDA approval in 1998, showed a 55% decrease in hospitalizatons.

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