Nirsevimab EMA regulatory submission accepted under accelerated assessment for respiratory syncytial virus (RSV) protection in all infants.

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose.

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.