FDA approves manufacturing line for RSV therapy - Becker's Hospital Review
Sanofi received FDA approval for a new manufacturing line to expand production of Beyfortus, a preventive therapy for RSV in infants. Beyfortus is the first long-acting monoclonal antibody approved by the FDA to prevent RSV-related lower respiratory tract disease in newborns and infants up to 24 months old. Sanofi has begun shipping doses to private healthcare providers and the CDC's Vaccines for Children program.
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FDA approves Sanofi and AstraZeneca's new filling line for Beyfortus, enabling expanded manufacturing capacity and supply in the U.S. for the 2024/2025 RSV season. Beyfortus, a long-acting antibody, was FDA-approved in July 2023 for infants and children up to 24 months old at severe risk of RSV infection. CDC analysis in March 2024 showed Beyfortus 90% effective at preventing RSV hospitalization.
FDA approves Sanofi and AstraZeneca's new filling line for Beyfortus, enabling expanded manufacturing and supply in the U.S. for the 2024/2025 RSV season. Beyfortus, a long-acting antibody, received FDA approval in July 2023 for infants and children up to 24 months old. CDC analysis in March 2024 showed 90% efficacy in preventing RSV hospitalization. RSV vaccines like GSK's Arexvy and Pfizer's Abrysvo are also approved for adults.
Sanofi received FDA approval for a new manufacturing line to expand production of Beyfortus, a preventive therapy for RSV in infants. Beyfortus is the first long-acting monoclonal antibody approved by the FDA to prevent RSV-related lower respiratory tract disease in newborns and infants up to 24 months old. Sanofi has begun shipping doses to private healthcare providers and the CDC's Vaccines for Children program.