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Japan panel approves second drug for mildly ill COVID-19 patients

A health ministry expert committee on Monday approved a single-dose monoclonal antibody-based treatment developed by British drugmaker GlaxoSmithKline PLC and U.S. firm Vir Biotechnology Inc., the second time it has given its OK to a drug for the treatment of mildly and moderately ill COVID-19 patients.

Following the approval of sotrovimab, which is given as a single dose intravenously, the health ministry is set to formally give its own fast-track OK to the treatment, which would also be the fifth medicine approved in Japan for treating COVID-19.

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A clinical trial involving 1,057 patients showed that the drug, which was granted emergency use authorization in the U.S. in May, reduced the risk of death and hospitalizations lasting longer than 24 hours by 79% compared with a placebo.

The approval, which comes three weeks after GlaxoSmithKline’s Japan unit submitted the application with the ministry, gives a boost to the arsenal of remedies available to treat mildly to moderately ill COVID-19 patients who do not require oxygen but are at risk of seeing their condition become severe.

Since its approval in July, a growing number of hospitals nationwide have already been using the other monoclonal antibody treatment, Ronapreve, which is composed of the artificially produced antibodies casirivimab and imdevimab. The final phase clinical trial overseas showed the drug, which Prime Minister Yoshihide Suga described as “revolutionary” and was developed by U.S. firm Regeneron Pharmaceuticals and Swiss drugmaker Roche, reduces the risk of hospitalization or death by 70.4% and shortened the duration of symptoms by four days.

While Ronapreve’s antibodies were developed from recovered COVID-19 patients, sotrovimab was originally identified during the SARS outbreak in 2003. Sotrovimab binds to a region of the spike protein, which gives it strong efficacy even against coronavirus variants, GlaxoSmithKline says. Data from in vitro studies has shown that sotrovimab maintains activity against currently circulating variants of concern and interest, including the delta and lambda versions, according to the drugmaker.

Sotrovimab has received an endorsement from the Committee for Human Medicinal Products in the European Union, and has also been granted temporary authorization in Canada, Italy, Singapore, the United Arab Emirates and other countries. In addition, it has received marketing authorization in Australia.

Sep 27, 2021

https://www.japantimes.co.jp/

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