Sanofi announces that the US FDA has agreed to review the Biologics License Application (BLA) for nirsevimab (co-developed with AstraZeneca), the first option for protection against RSV (respiratory syncytial virus) for all infants.

In several trials, the product has been shown to confer uniform protection of around 80% against RSV infections requiring medical management, in full-term and premature infants.

The FDA has indicated that it will endeavor to expedite its review, and is expected to issue its decision in the third quarter of 2023. Sanofi also points out that nirsevimab has been approved following accelerated reviews in the EU and the UK.

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