February 17, 2022: “AstraZeneca’s Marketing Authorisation Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the prevention of medically attended lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season.
Nirsevimab is being developed by AstraZeneca in collaboration with Sanofi.
Nirsevimab is the first investigational long-acting antibody designed to provide RSV protection for all infants.
It is being developed as a single dose for infants experiencing their first RSV season and for children at higher risk in their second RSV season.
The MAA is based on positive results from the MELODY Phase III trial, MEDLEY Phase II/III trial, and Phase IIb trial which demonstrated nirsevimab’s safety and efficacy in providing protection against the virus for all infants with a single dose for the RSV season.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment as it was deemed of major interest for public health and therapeutic innovation.
Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure and follows the EMA granting access to the PRIority MEdicines (PRIME) scheme in 2019.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “Each year, 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 respiratory syncytial virus as shown by the extensive clinical trial programme.”
Jean-François Toussaint, Global Head of Research and Development, Sanofi, said: “Respiratory syncytial virus is a leading cause of hospitalisation in all infants, and recent spikes in bronchiolitis and hospitalisations caused by respiratory syncytial virus infection around the globe further demonstrate the need for a preventative option that can help protect all infants.
We are pleased to receive this regulatory filing acceptance and remain confident in nirsevimab’s potential to change the current RSV prevention paradigm as a possible single dose option that may offer sustained protection to all infants for the season”
Data from the MELODY and MEDLEY trials will be published in an upcoming peer-reviewed journal.”
