AstraZeneca and Sanofi Publishes Results of Nirsevimab in P-III (MELODY) Trial for the Treatment of RSV in the NEJM
Shots:
- The P-III (MELODY) trial evaluates nirsevimab (50/100mg, IM) vs PBO in a ratio (2:1) in 1490 infants at term or late preterm with RSV
- The trial met its 1EPs i.e., 74.5% reduction in LRTI. In terms & preterm infants (≥28wks. gestational age), the therapy showed 77.3% efficacy against RSV-associated hospitalizations, reduction in risk of RSV-associated hospitalizations, safety profile remains consistent with prior reported results with no differences in safety results in the P-III (MELODY) & P-IIb study
- Additionally, 6 of 994 infants were hospitalized in nirsevimab for RSV LRTI & 8 of 496 infants in PBO. The (MEDLEY) trial results were also published in the NEJM & regulatory submissions are expected in H1’22
Ref: Sanofi | Image: Sanofi
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