AstraZeneca-Sanofi's antibody for RSV protection in infants gets EU accelerated assessment
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AstraZeneca (NASDAQ:AZN) said on Feb. 17 that the European Medicines Agency accepted its application for nirsevimab under an accelerated assessment for the prevention of lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season.

The British drugmaker is developing nirsevimab in collaboration with Sanofi (NASDAQ:SNY).
AstraZeneca said 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 company's Marketing Authorization Application (MAA) is backed by data from the MELODY Phase 3 trial, MEDLEY phase 2/3 study, and phase 2b trial which showed nirsevimabâs safety and efficacy in providing protection against the virus for all infants with a single dose for the RSV season.
The EMAâs Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment, which 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.
The company said additional regulatory submissions are planned to take place in 2022.