Nirsevimab EMA filing accepted under accelerated assessment

18 February 2022

The Marketing Authorization 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 UK-based AstraZeneca (LSE: AZN) in collaboration with French pharma major Sanofi (Euronext: SAN).

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.

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