Senators urge action on Beyfortus supply as RSV threat looms

Beyfortus (nirsevimab), along with vaccines, is one of the latest weapons against RSV.

Approved on July 17, 2023, AstraZeneca and Sanofi’s Beyfortus (nirsevimab-alip) occupies a unique niche as a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor for neonates and infants. With RSV rates surging, the drug quickly fell into a shortage. The CDC and FDA recently made available more than 77,000 additional doses of Beyfortus. Meanwhile, Senate Democrats Tammy Duckworth, Kirsten Gillibrand, Ron Wyden, Ed Markey, Richard Blumenthal, Jon Ossoff, and Elizabeth Warren pushed AstraZeneca and Sanofi for action regarding the supply shortage.

Unprecedented demand

Facing criticism for the supply shortfall, Sanofi noted it had encountered “higher than anticipated demand” and said it had an “aggressive supply plan” in place to exceed past performance of pediatric vaccine launches. AstraZeneca also noted…

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  • November 21, 2023
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The recent FDA thumbs-up for Beyfortus could kickstart a new chapter in RSV prevention

Respiratory syncytial virus (RSV) is a common cause of severe lower respiratory tract infections like pneumonia and bronchiolitis in infants and young children. Traditionally there have been no approved treatments for RSV infections, with care being largely supportive. But the landscape is quickly changing.

The FDA recently approved Beyfortus (nirsevimab), the first immunoprophylactic to prevent RSV disease in newborns, infants and toddlers. On the RSV vaccine front, FDA also approved GSK‘s (NYSE:GSK) Arexvy. Other RSV vaccine candidates are waiting in the wings.

A shift in the RSV treatment landscape

Beyfortus is a monoclonal antibody developed by AstraZeneca and Sanofi that provides protection against RSV with a single intramuscular injection. It is the first innovation in RSV prevention in over two decades. Until recently, the only preventive therapy on the market was Synagis, a monoclonal antibody used to help prevent serious lung disease from RSV in …

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  • July 17, 2023
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