Sanofi: review of a BLA application in RSV in the United States
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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