GSK and Vir Biotech COVID-19 antibody gets Japanese approval

JAPAN – Sotrovimab, a COVID-19 antibody therapy developed by GlaxoSmithKline in collaboration with Vir Biotechnology has received Special approval for emergency use in Japan for patients who are not severely ill.

Sotrovimab, is a monoclonal antibody that attacks the virus, is given intravenously, became the fifth medicine in Japan for treating COVID-19.

The fast-tracked approval of sotrovimab came after a health ministry expert panel gave a positive nod for the therapy.  

FDA granted Sotrovimab an Emergency Use Authorization (“EUA”) in May for the treatment of mild-to-moderate COVID-19 in people aged 12 and above.

A clinical trial involving 1,057 patients found that the drug reduced the risk of death and hospitalizations lasting more than 24 hours by 79 percent when compared to a placebo.

Sotrovimab is the second COVID-19 drug that has been authorized in in Japan for patients who are not severely ill, after the antibody cocktail Ronapreve, developed in collaboration between Regeneron and Roche, and sold by Chugai Pharmaceutical Co in Japan.

Since its approval in July, a growing number of hospitals across Japan have been using Ronapreve, a monoclonal antibody treatment composed of the artificially produced antibodies casirivimab and imdevimab.

The drug, described as “revolutionary” by Prime Minister Yoshihide Suga and developed by US firm Regeneron Pharmaceuticals and Swiss drugmaker Roche, reduced the risk of hospitalization or death by 70.4 percent and shortened the duration of symptoms by four days.

Dr. Joe Chiba, emeritus professor at Tokyo University of Science, stated that the drug will broaden treatment options at a time when some high-risk patients, such as those with rheumatoid arthritis or cancer, are not seeing an increase in coronavirus neutralizing antibodies despite completing a two-shot COVID-19 vaccine regimen due to the use of immunosuppressive drugs.

While Ronapreve antibodies were developed from recovered COVID-19 patients, sotrovimab was discovered during the 2003 SARS outbreak.

According to GlaxoSmithKline, sotrovimab binds to a region of the spike protein, giving it strong efficacy even against coronavirus variants.

According to the British drugmaker, data from in vitro studies show that sotrovimab retains activity against currently circulating variants of concern and interest, including the delta and lambda versions.

Unlike Ronapreve, sotrovimab binds to SARS and otrhe variants of the coronavirus, and according to Vir Biotechnology, it exhibits potent effector functions in lab studies, allowing the antibody to engage and recruit the rest of the immune system to destroy already infected cells.

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