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2022-09-19| Trials & Approvals

AstraZeneca, Sanofi’s RSV Antibody Recommended For Approval In EU

by Joy Lin
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AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been recommended for EU approval by CHMP for the prevention of respiratory syncytial virus (RSV) infection in infants. The recommendation is based on results from three clinical trials of Beyfortus, which demonstrated protection against the disease during the RSV season with a single dose. 

If approved, Beyfortus will be the first and only single-dose passive immunization for the general infant population. 

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Protection Against A Common Disease

RSV is the most common cause of lower respiratory tract infections (LRTIs) and a leading cause of hospitalization in infants. The disease was estimated to cost the global healthcare system €4.82 billion ($4.81 billion) in 2017. 

The current standard of care for RSV prophylaxis is Synagis (palivizumab), which was approved in 1998. Synagis is indicated for high-risk infants and is given several times over the RSV season. 

Beyfortus is designed to be administered via a single intramuscular injection which would confer protection against RSV during the viral season. 

The positive opinion by CHMP was based on results from the Beyfortus clinical development program, which includes the Melody Phase 3, Medley Phase 2/3, and Phase 2b trials. 

In Melody and Phase 2b trials, Beyfortus reduced the incidence of LRTIs caused by RSV compared to the placebo in a single dose. No clinically meaningful differences in safety results between the Beyfortus and placebo groups were seen. Beyfortus also showed a comparable safety and tolerability profile to Synagis (palivizumab) in the Medley 2/3.    

Beyfortus has been granted Breakthrough Therapy Designation in China and the US. The antibody is also included in EMA’s PRIME scheme and labeled a priority medicine in Japan. 

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