Japan approves GSK’s mAb for COVID-19 treatment

Japanese Ministry of Health, Labour and Welfare (MHLW) has given approval to Xevudy (generic name sotrovimab), a singledose monoclonal antibody (mAb) developed by the British firm GlaxoSmithKline

(GSK), for the treatment of COVID-19, as a Special Approval for Emergency (SAE) under Article 14-3(1) of the Pharmaceutical Affairs Law. Xevudy is a SARS-CoV-2 monoclonal antibody being developed globally by GSK and Vir Biotechnology

Inc. With regard to the domestic supply of Xevudy, agreement has been reached with the Japanese government for their purchase and distribution of sotrovimab. GSK will continue to work together with the Japanese government to ensure a prompt and appropriate supply. XEVUDY 500mg for intravenous injection is approved for the treatment of mild to moderate COVID-19 patients who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.