The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The FDA granted this approval to the UK’s AstraZeneca (LSE: AZN), which is developing the drug with France’s Sanofi (Euronext: SAN). The companies aim to make Beyfortus available in the USA ahead of the upcoming 2023-24 RSV season.
They also currently expect Beyfortus will be discussed at the anticipated August 3 Advisory Committee on Immunization Practices (ACIP) meeting.
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