GSK: EMA evaluates investigational Covid antibody VIR-7831
(CercleFinance.com) - The European Medicines Agency (EMA) today announced that it is reviewing the currently available data on VIR-7831, an investigational antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology for people over 12 years of age who weigh over 40 kg with mild-to-moderate Covid-19, which is at risk of progression into a severe form of the disease.
The study will enable the EMA to provide EU-wide recommendations for this treatment, enabling national authorities to take a stance even before it is marketed.
Preliminary results from a phase III study have already shown a reduction in hospital admissions of more than 24 hours and around 85% in deaths, compared to placebo.
The EMA's Committee for Medicinal Products for Human Use (CHMP) intends to re-evaluate these results and conduct a continuous and more comprehensive review before a possible marketing authorisation application is made.
The EMA states that it will communicate results once the review has been completed.
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The study will enable the EMA to provide EU-wide recommendations for this treatment, enabling national authorities to take a stance even before it is marketed.
Preliminary results from a phase III study have already shown a reduction in hospital admissions of more than 24 hours and around 85% in deaths, compared to placebo.
The EMA's Committee for Medicinal Products for Human Use (CHMP) intends to re-evaluate these results and conduct a continuous and more comprehensive review before a possible marketing authorisation application is made.
The EMA states that it will communicate results once the review has been completed.
Copyright (c) 2021 CercleFinance.com. All rights reserved.