EMA to review GSK, Vir COVID-19 mAb

By The Science Advisory Board staff writers

April 16, 2021 -- GlaxoSmithKline (GSK) and Vir Biotechnology announced that the European Medicines Agency (EMA) has started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody (mAb) for the treatment of adults and adolescents 12 years old and over with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.

The review is being carried out by the EMA's Committee for Human Medicinal Products and will provide European Union-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal marketing authorization application.

The review will include data from an interim analysis of efficacy and safety data from the phase III COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early (COMET-ICE) trial, which evaluated VIR-7831 as a monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 randomized patients, demonstrated an 85% reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary end point of the trial.


Copyright © 2021 scienceboard.net
 

Create an Account

Already have an account? Sign in Here

To access all ScienceBoard content create a free account now:



Email Address:  

First Name:

Last Name:

Learn about ScienceBoard

Get the latest life sciences research and industry news, delivered straight to your inbox, for free.

Why subscribe?

ScienceBoard is uniquely focused on the business of research, addressing the biggest problems that the biomedical industry face. You’ll get breaking news, events coverage, and deep dives into the science that drives innovation, delivered to your inbox daily.

 
I have read and agree to the privacy policy and terms of service and wish to opt-in for ScienceBoard.net.

Email Preferences



Letter from the Editor Please send me twice-weekly roundups of all the latest life research and industry news.
SAB Announcements Please send me the latest announcements from The Science Advisory Board and their partners.
Spotlight Receive notifications about new content, services, or educational resources designed to help you sharpen your skills and grow professionally.