MHRA Grants Approval of Beyfortus(nirsevimab) for Prevention of RSV Disease in Infants

Following European Commission approval earlier this month, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. RSV is a common and highly contagious seasonal virus, infecting 90% of children by the age of two. Nirsevimab is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Nirsevimab is being developed jointly by Sanofi and AstraZeneca.

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“Today is a landmark day for RSV prevention, as decades of research and development come together for approval of a broadly protective option against RSV disease. Once launched, nirsevimab will offer parents the ability to help protect their babies during their first RSV season.”

Iskra Reic
Vaccines and Immune Therapies Unit, AstraZeneca
“Nirsevimab is the first single-dose passive immunisation against respiratory syncytial virus to gain approval in Great Britain and is also the first and only preventative option approved for a broad infant population. Today’s marketing authorisation of nirsevimab marks a significant achievement for the scientific community and addresses a persistent, global unmet need in RSV prevention.”

The MHRA approved nirsevimab following the European Commission’s approval earlier this month. The approval was based on results from the nirsevimab clinical development programme, including the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials. In the MELODY and Phase 2b trials, nirsevimab met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose. The safety profile of nirsevimab was similar to placebo. Nirsevimab also demonstrated a comparable safety and tolerability profile to palivizumab in the Phase 2/3 MEDLEY trial.

RSV is the most common cause of LRTI, including bronchiolitis and pneumonia, in infants. It is also a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in healthy infants born at term. In the UK, around 30,000 children under the age of five are hospitalised every year due to RSV and it causes approximately 33 deaths per year in children under five. The economic impact of RSV is estimated at around £80 million each year in the UK.