Thursday, January 5, 2023

Sanofi, AstraZeneca: FDA accepts nirsevimab application as first protective option v. RSV

 FDA accepts nirsevimab application as first protective option against RSV disease for all infants

  • Nirsevimab would be the first broadly protective option against RSV disease designed for all infants, if approved
  • Nirsevimab delivered consistent protection of approximately 80% against medically attended RSV disease across several trials in healthy term and preterm infants and has been approved under accelerated review in the EU and the UK

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