Shots:
The results from a prespecified pooled analysis of the P-III (MELODY) & P-IIb trials evaluates nirsevimab (50mg, IM) vs PBO in a ratio (2:1) in 1490 & 1453 infants against medically attended LRTI due to RSV through 150 days post-dose
The results from both trials showed an efficacy of 79.5% in infants who received the optimized dosing regimen of 50mg. The safety profile was similar to prior trials & the regulatory submissions are expected to be initiated in 2022
Under the terms of the 2017 agreement, Sanofi & AstraZeneca collaborated to develop & commercialize nirsevimab. AstraZeneca will lead development & manufacturing activities while Sanofi will lead commercialization activities & record revenues
Ref: Globenewswire | Image: Sanofi
