Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to help ensure the majority of doses are available ahead of RSV season. The US market is anticipated to have enough supply so that every eligible baby born outside of the season will have access to immunization at a regular checkup and those born during the season will have access at birth. BEYFORTUS is the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
In collaboration with AstraZeneca, which leads BEYFORTUS development and manufacturing, doses have already been produced and packaged on a new filling line for BEYFORTUS. With the recent FDA approval of this filling line, these doses are now ready to ship, expanding supply for the Northern Hemisphere ahead of the 2024/2025 RSV season (November – March).2 Another filling line is expected to provide doses for the 2024/2025 season, adding additional production capacity. Sanofi continues to work with AstraZeneca to build inventory for this and future seasons.
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