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Sanofi/AstraZeneca Win Beyfortus Approval To Prevent RSV In US Infants

Prophylactic Antibody A Key Asset In Sanofi’s Vaccine Portfolio

 
• By Mandy Jackson

Sanofi, which leads commercialization under its 2017 deal with AstraZeneca, may soon compete with a maternal RSV vaccine from Pfizer, but the US may have room for only one infant-protecting option.

Portrait of asian parent hands holding newborn baby
Beyfortus is approved for newborns and toddlers in their second RSV season • Source: Shutterstock

Sanofi received an important win in the US on 17 July when the US Food and Drug Administration approved the AstraZeneca PLC-partnered antibody Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) in infants, a key market for one of prime products in the French big pharma’s push to turn its €3bn vaccines portfolio into a €10bn ($10.9bn) business by 2030. However, a Beyfortus challenger that could still garner significant US market share is awaiting approval next month.

Pfizer Inc.’s RSV vaccine Abrysvo was approved for older adults in June shortly after the FDA approved GSK plc’s vaccine Arexvy, also for older adults, but the agency is considering Pfizer’s supplemental biologics license application (sBLA) for Abrysvo as a vaccine for pregnant mothers to prevent RSV in their infants, with a decision due in August. GSK ended development of Arexvy as a maternal vaccine in 2022 due to safety concerns

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