Vir Biotechnology Announces First Marketing Authorization for its First Commercial Product, Sotrovimab, Granted in Australia

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[{"type":"text","content":"– First monoclonal antibody authorized in Australia –\nSAN FRANCISCO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization for sotrovimab (under the brand name, Xevudy®), a monoclonal antibody 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 initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalization or death. Sotrovimab is the first monoclonal antibody approved in Australia. As part of its overarching effort to address COVID-19, the Australian Government also recently announced an agreement to purchase sotrovimab, the first supply of which arrived in the country last week. The TGA had previously granted sotrovimab a provisional determination in April, which provides a mechanism for accelerating the provisional marketing authorization of promising new medicines. This approval pathway allows companies to apply for registration of medicines for conditions with high unmet clinical need based on promising early clinical data. Globally, sotrovimab is authorized for emergency use in the U.S., received a positive scientific opinion from the Committee for Human Medicinal Products (CHMP) in the European Union (EU), and has been granted temporary authorization in Bahrain, Canada, Egypt, Italy, Kuwait, Qatar, Singapore and the United Arab Emirates. George Scangos, Ph.D., chief executive officer of Vir, said: “The provisional approval of sotrovimab in Australia marks an important milestone for Vir, as it is the first marketing authorization of our first commercial product. It also represents an important step forward in the Australian Government’s efforts to combat the pandemic and prevent the most severe effects of COVID-19, particularly in the face of new and emerging variants. We eagerly anticipate additional regulatory decisions around the world in the coming months and look forward to working with our partner, GSK, to expand patient access to a much-needed treatment opt...

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