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).
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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.
