AZ Secures EU Fast-Tack Review For Nirsevimab

First Filing Worldwide Submitted To EMA For Novel Anti-RSV Immunization For All Infants

28 Feb 2022

• By Maureen Kenny

There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.

Intubated child with RSV being cared for in ICU — Respiratory syncytial virus is a leading cause of hospitalization in all infants • Source: Alamy

AstraZeneca PLC has secured fast-track review in the EU for nirsevimab, the investigational long-acting antibody it is developing in collaboration with Sanofi which it says has the potential to be the first immunization to offer protection for all infants against respiratory syncytial virus (RSV).

The marketing authorization application (MAA) that AZ has filed for nirsevimab with the European Medicines Agency is for the prevention...