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Sanofi and AstraZeneca Report Results of Nirsevimab in P-III (MELODY) and P-IIb Trials for the Treatment of Respiratory Syncytial Virus

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Sanofi and AstraZeneca Report Results of Nirsevimab in P-III (MELODY) and P-IIb Trials for the Treatment of Respiratory Syncytial Virus

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III (MELODY) and P-IIb Trials for the Treatment of Respiratory Syncytial Virus

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  • 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

Click here to­ read the full press release 

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