FDA Approves AstraZeneca’s Beyfortus

The Food and Drug Administration has approved an AstraZeneca-developed monoclonal antibody, Beyfortus, in an effort to protect infants and young children from severe illness caused by RSV, the number 1 cause of infant hospitalizations in the U.S. Beyfortus is expected to be recommended by the Advisory Committee on Immunization Practices (ACIP) shortly. However, it still needs the approval of CDC Director Mandy Cohen before it can be used widely.

Beyfortus, already licensed in the EU, the UK, and Canada, can significantly reduce the incidence of RSV-triggered lower respiratory tract infections and related hospitalizations. A Phase 3 clinical trial showed that the antibody reduced relevant medical care by 76.4% and cut hospitalizations by 76.8% in healthy babies. The approval of Beyfortus preempts a similar product from Pfizer that generates antibodies passing from a vaccinated pregnant woman to her fetus during late pregnancy.

However, concerns from experts about maximizing the benefits of these two different approaches without breaking the bank have been raised, particularly with the cost of the monoclonal antibodies expected to be substantially higher than a vaccine. Furthermore, costs will impact low-income families if the vaccine treatment is not covered by the Vaccines for Children program.

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What We’re Reading to Learn More: 

• We’ll soon have tools to protect infants against RSV. Can we put them to good use?, STAT
• Beyfortus approved in the US for the prevention of RSV lower respiratory tract disease in infants, AstraZeneca
• FDA approves new RSV drug to protect infants, toddlers, BioPharma Dive