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Vir Biotechnology, GlaxoSmithKlineSeek EUA for COVID-19 Monoclonal Antibody Treatment

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eMediNexus    14 March 2021

An independent data monitoring committee is recommending that enrollment in a phase 3 trial of a monoclonal antibody for COVID-19 should be stopped as interim results point to an 85% decrease in hospitalizations or death, announced two companies.

Vir Biotechnology and GlaxoSmithKline stated that they intend to immediately seek emergency use authorization (EUA) from the US Food and Drug Administration (FDA) as well as authorizations in other countries for the treatment, VIR-7831. The recommendation follows results of the randomized, double-blind, multicenter, placebo-controlled COMET-ICE trial. The trial included 583 patients with mild to moderate COVID-19. The companies further stated that according to a new study, about to be published in bioRxiv, VIR-7831 was effective against the UK, South African, and Brazilian variants of the virus… (Medscape)

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