UK MHRA Approves Beyfortus to Prevent RSV in newborns


The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Beyfortus (nirsevimab) to treat respiratory syncytial virus (RSV) lower respiratory tract disease in the infants and newborns during their first RSV season. This approval come after the European Commission approve Beyfortus earlier this month.

According to studies, about 90 percent of children by 2 years of age get infected by RSV, which is a contagious and common seasonal virus. Beyfortus (nirsevimab), jointly produced by AstraZeneca and Sanofi, is claimed to be the first single-dose RSV treatment option for newborns and infants, including those born healthy or with some particular health conditions.

This is a new milestone for RSV prevention, as decades of research and development come together for the approval of Beyfortus against RSV disease. Once launched, Beyfortus will offer parents the ability to help protect their babies during the first RSV season, says Thomas Triomphe, executive VP for vaccines at Sanofi.

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According to Iskra Reic, executive VP for vaccines and immune therapy at AstraZeneca, Beyfortus (Nirsevimab) is the first single-dose therapy against RSV to get approved in the United Kingdom, and it is also the first treatment option to be approved for a broad infant population.

Iskra Reic added that this marketing authorisation highlights a significant achievement for the scientific community, and addresses a global unmet need in RSV prevention.