GSK: applies to FDA for its anti-covid antibody
(CercleFinance.com) - GlaxoSmithKline (GSK) and Vir Biotechnology today announced that they have applied to the US FDA for an Emergency Use Application (EUA) for VIR-7831 (GSK4182136), an investigational antibody for people over 12 years of age and 40kg in weight with mild-to-moderate Covid-19, which could worsen to a severe form of the disease.
This request is based on the results of a phase 3 study which showed an 85% reduction in hospital admissions or death in patients receiving this treatment compared to placebo.
GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulatory bodies to make VIR-7831 available to patients with COVID-19 as soon as possible.
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This request is based on the results of a phase 3 study which showed an 85% reduction in hospital admissions or death in patients receiving this treatment compared to placebo.
GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulatory bodies to make VIR-7831 available to patients with COVID-19 as soon as possible.
Copyright (c) 2021 CercleFinance.com. All rights reserved.