TGA provisionally approves COVID-19 treatment sotrovimab

20 August 2021

Australia’s Therapeutic Goods Administration (TGA) today granted provisional approval to the local subsidiary of UK pharma major GlaxoSmithKline (LSE: GSK) for its COVID-19 treatment - sotrovimab (trade name Xevudy) - making it the second COVID-19 treatment to receive regulatory approval in Australia.

Australia is the first OECD country to issue a formal regulatory approval for sotrovimab, which has been developed by GSK and partner the USA’s Vir Biotechnology (Nasdaq: VIR).

Sotrovimab, a monoclonal antibody treatment, is provisionally approved and included in the Australian Register of Therapeutic Goods (ARTG) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death.

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