The European Medicines Agency (EMA) has accepted AstraZeneca’s marketing authorisation application (MAA) for nirsevimab under an accelerated assessment for respiratory syncytial virus (RSV) protection in all infants.
Being developed by AstraZeneca and Sanofi, nirsevimab is the first investigational long-acting antibody that is intended to provide RSV protection for all infants.
It is now being assessed by the EMA for preventing medically attended lower respiratory tract infections (LRTI) in all infants through their first RSV season.
The antibody is being developed as a single dose for children at higher risk in their second RSV season as well as for infants experiencing their first RSV season.
AstraZeneca stated that the MAA is supported by the data obtained from the MEDLEY Phase II/III trial, the MELODY Phase III trial and the Phase IIb study.
These studies showed the safety and efficacy of nirsevimab in offering protection for all infants against the virus with the administration of a single dose for the RSV season.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA granted accelerated assessment for nirsevimab as it was considered to be of major interest for therapeutic innovation and public health.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Each year, the respiratory syncytial virus causes seasonal epidemics of lower respiratory tract infections in infants and preventative options are currently limited to infants at higher risk.
“We are excited that the EMA has accepted this regulatory submission under an accelerated assessment procedure, as nirsevimab has the potential to be the first immunisation to offer protection for all infants against the respiratory syncytial virus as shown by the extensive clinical trial programme.”
Furthermore, the company plans for additional regulatory submissions this year.