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GSK/VIR sotrovimab receives positive EMA opinion
GSK/VIR sotrovimab receives positive EMA opinion.
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[{"type":"text","content":"\n \n \n \n RNS Number : 4755Z\n GlaxoSmithKline PLC\n 21 May 2021\n \n \n \n \n Issued: 21 May 2021, London UK\n \n \n \n \n \n EMA issues positive scientific opinion on GSK and Vir Biotechnology's sotrovimab for the early treatment of COVID-19\n \n \n \n \n \n · \n Opinion based on the EMA's Committee for Human Medicinal Products (CHMP) review of available data on sotrovimab (previously VIR-7831) for the early treatment of COVID-19.\n \n \n · \n EU member states can use the CHMP positive scientific opinion when making national decisions about the early use of sotrovimab prior to EMA marketing authorisation.\n \n \n · \n Discussions with global regulators regarding authorisations in additional countries continue to advance.\n \n \n \n \n \n GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion following the referral of sotrovimab to the CHMP under Article 5(3) of Regulation 726/2004. The opinion relates to the use of sotrovimab for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.\n \n \n \n \n \n The CHMP opinion under Article 5(3) can now be considered by the national authorities in EU member states when taking evidence-based decisions on the early use of the medicine prior to marketing authorisation.\n \n \n \n \n \n \n Christopher Corsico, Senior Vice President, Development, GSK, said\n \n : \"As the COVID-19 pandemic continues and the virus generates new variants of concern, including those that recently emerged in India, the need for therapies that can slow the progression of disease in patients who are at high risk for developing severe complications remains a top priority. Monoclonal antibody treatments are a critical part of a comprehensive solution to COVID-19, especially as less than 40% of adults across EU member states have received at least one dose of a vaccine to date[1]. We are encouraged by this positive scientific opinion from the EMA, as it hopefully brings us closer to making sotrovimab available for patients across Europe.\" \n \n \n \n \n \n \n George Scangos, Ph.D., chief ex...