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AstraZeneca/Sanofi’s Nirsevimab Nears US FDA Approval After Overwhelmingly Positive Adcomm

 
• By Derrick Gingery

When patients should receive the RSV prevention treatment was the subject of much debate even as the Antimicrobial Drugs Advisory Committee voted nearly unanimously that it should be approved for infants and neonates.

FDA AMDAC meeting screenshot
Advisory committee members voted that the benefits outweigh the risks of the proposed RSV prevention treatment nirsevimab. • Source: Screenshot

Members of the US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee were not too worried about whether AstraZeneca PLC and Sanofi’s RSV prevention treatment nirsevimab should be given to infants and neonates, but did question when patients should receive it.

Nirsevimab, which has the provisionally approved trade name Beyfortus, is proposed for prevention of RSV lower respiratory tract disease in...

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