European Commission Approves First Single-Dose RSV Preventative Option for Newborns and Infants

Strategic Insights -

The European Commission has granted marketing authorisation to Beyfortus, a single-dose preventative option against respiratory syncytial virus (RSV) disease, for newborns and infants across the European Union. This marks a significant milestone in the fight against RSV, a common and highly contagious seasonal virus that infects nearly all children by the age of two. Beyfortus has been developed jointly by AstraZeneca and Sanofi using AstraZeneca's YTE technology and is the first and only single-dose RSV passive immunisation for the broad infant population.

Key Takeaways:

  • Beyfortus has been approved in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season.
  • The approval is based on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II/III and Phase IIb trials.
  • Beyfortus has met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% (95% CI 49.6, 87.1; p.
  • The recommended dose of Beyfortus is a single intramuscular injection of 50 mg for infants with body weight.
  • Beyfortus has been granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world, including Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration.
  • RSV is a leading cause of hospitalization in all infants, with approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations globally in 2019.
  • The European Commission's approval of Beyfortus is a landmark achievement for the scientific community in addressing a persistent, global unmet need in RSV prevention.

Silke Mader, Chairwoman of the Executive Board and Co-founder of the European Foundation for the Care of Newborn Infants (EFCNI), said: "Respiratory syncytial virus represents a health threat among infants, and each year we see the impact it can have on families, healthcare providers and the healthcare system. At EFCNI, we are excited about the opportunity to expand prevention efforts to all infants, as we believe this can help ease the current emotional, physical and financial burdens of RSV."

Statistics:

  • Beyfortus has been shown to reduce the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% (95% CI 49.6, 87.1; p.
  • RSV is the most common cause of LRTI, including bronchiolitis and pneumonia in infants, with approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations globally in 2019.
  • Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.
  • RSV-related direct medical costs, globally, including hospital, outpatient and follow-up care, were estimated at $4.82 billion in 2017.

Sources:

1. European Commission. (2022). EU regulatory news. Contify.

2. AstraZeneca and Sanofi. (2022). Beyfortus receives European Commission approval for prevention of RSV lower respiratory tract disease in newborns and infants. Contify.

3. World Health Organization. (2020). Respiratory Syncytial Virus (RSV). Contify.

4. National Institute of Child Health and Human Development. (2020). Respiratory Syncytial Virus (RSV) Infection. Contify.

5. RSV Foundation. (2020). What is RSV? Contify.