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March 29, 2021

Coronavirus company news summary – GSK and Vir submit EUA application to FDA for Covid-19 monoclonal antibody treatment – EMA recommends Celltrion’s regdanvimab for severe Covid-19

By Chris Lo

GSK and Vir Biotechnology have submitted an application for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for use of investigational monoclonal antibody VIR-7831 (GSK4182136) in the treatment of adults and adolescents with mild symptoms of Covid-19. The two companies made the EUA submission based on the interim analysis of effectiveness and safety data from their Phase III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial.

The European Medicines Agency (EMA) has advised EU member states to use Celltrion Group’s regdanvimab (CT-959) for patients with severe Covid-19, based on a positive opinion given by the agency’s Committee for Medicinal Products for Human Use (CHMP). Regdanvimab has demonstrated an ability to neutralise the SARS-CoV-2 wild-type virus, as well as prominent mutations such as the UK variant (B.1.17).

The Russian Direct Investment Fund (RDIF) has announced that the health ministry of Antigua and Barbuda has authorised the use of Sputnik V, the Russian-made Covid-19 vaccine. Sputnik V has now received authorisation for use in 57 countries across the world making it the second most approved coronavirus vaccine in terms of government approvals.

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