By Kyle Morris

 

AstraZeneca PLC said Friday that nirsevimab, a treatment for the prevention of respiratory syncytial virus lower respiratory tract disease in infants, has been recommended for approval in the EU.

The Anglo-Swedish pharma major said the Committee for Medicinal Products for Human Use of the European Medicines Authority recommended the treatment, know commercially as Beyfortus, based on a clinical trial program which demonstrated protection against RSV disease during the RSV season with a single dose.

Beyfortus is being developed jointly by AstraZeneca and Sanofi and is an investigational long-acting antibody designed for all infants for protection against RSV disease from birth. Beyfortus would be the first preventative option for newborn and infant population.

In trials, Beyfortus met its primary endpoint of reducing infections caused by RSV during the season versus placebo.

 

Write to Kyle Morris at kyle.morris@dowjones.com

 

(END) Dow Jones Newswires

September 16, 2022 02:30 ET (06:30 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Sanofi (EU:SAN)
Historical Stock Chart
From Nov 2022 to Dec 2022 Click Here for more Sanofi Charts.
Sanofi (EU:SAN)
Historical Stock Chart
From Dec 2021 to Dec 2022 Click Here for more Sanofi Charts.