RSV is a common and highly contagious seasonal virus, infecting nearly all children by the age of two, causing bronchiolitis and pneumonia in infants.
Beyfortus is the first and only single-dose RSV passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions, said the developers.
And the EU Commission is the first regulatory body to authorize the monoclonal antibody.
The approval was based on results from the Beyfortus clinical development program and follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2022.
In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialize nirsevimab. Under the terms of that deal, AstraZeneca leads all development and manufacturing activities, and Sanofi leads commercialization initiatives.
'Significant achievement for the scientific community'
This authorization represents decades of research and development, said Thomas Triomphe, executive VP vaccines, Sanofi. His counterpart in AstraZeneca, Iskra Reic, called it a significant achievement for the scientific community.
“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,” said Silke Mader, chairwoman of the executive board and cofounder of the European Foundation for the Care of Newborn Infants (EFCNI).
Approval pathway globally
Beyfortus has also been granted regulatory designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation, Breakthrough Therapy Designation from the US FDA; and the treatment was named ‘a medicine for prioritized development’ under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED).