Tuesday, May 10, 2022

GSK, Vir Biotech seek emergency use authorisation for COVID-19 antibody




GlaxoSmithKline (GSK) and Vir Biotechnology have submitted a request to the US Food and Drug Administration (FDA), seeking an emergency use authorisation (EUA) for their COVID-19 antibody VIR-7831.

The EUA application is seeking authorisation for VIR-7831, an investigational dual-action monoclonal antibody (mAb), for the treatment of adults and adolescents with mild-to-moderate COVID-19 who are at risk of progression to hospitalisation or death.

The submission is based on an interim analysis of efficacy and safety data from the Phase III COMET-ICE trial, which demonstrated an 85% reduction in hospitalisation or death in patients receiving VIR-7831 compared to placebo.

Following this positive result, the independent data monitoring committee recommended that the trial be stopped for enrolment, due to evidence of ‘profound efficacy’.

GSK and Vir Biotech added that data from the COMET-ICE trial will also form the basis of a biologics license application (BLA) submission to the FDA.

The companies are also continuing discussions with the European Medicines Agency (EMA) and other global regulators for the potential approval of VIR-7831 to treat patients with COVID-19.



Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...