Coronavirus Update: Japan Approves Sotrovimab

Japan approves a second antibody therapy for COVID-19 in short order, while India gives the go-ahead to a local clinical program for Novavax/Serum Institute's recombinant protein vaccine candidate. 

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Japan Nod for second antibody therapy for COVID-19

 

Japan Approves Sotrovimab As Second MAb For COVID-19

Japan’s ministry of health, labour and welfare issued an emergency use authorization (EUA) on 27 September for GlaxoSmithKline plc/Vir Biotechnology, Inc.’s single-dose monoclonal antibody Xevudy (sotrovimab), for the treatment of patients with mild-to-moderate COVID-19 who do not require supplemental oxygen but are at high risk of progressing to severe disease. 

An approval application was submitted only on 6 September.  (Also see "Coronavirus Update: Sotrovimab Filed For EUA In Japan" - Scrip, 14 Sep, 2021.)

GSK’s Japanese subsidiary said that an agreement had already been reached with Japan’s government for the purchase and distribution of Xevudy but did not provide further details, saying only that it would work to ensure “prompt and appropriate supply.” The standard approved dose in Japan for children aged 12 or over and weighing at least 40kg and adults is a single intravenous infusion of 500mg.

The new approval was based on positive results announced in June from the 1,057-patient Phase II/III COMET-ICE trial among high-risk adult outpatients with mild-to-moderate disease. This met its primary endpoint, showing a significant adjusted 79% relative risk reduction (p<0.001) in hospitalization for more than 24 hours, or death due to any cause, by day 29 versus placebo.  (Also see "Coronavirus Update: Veklury Shows Mortality Benefit In Real-World Data Analyses" - Scrip, 22 Jun, 2021.)

Sotrovimab becomes the second antibody to be approved in Japan for COVID-19 after Chugai Pharmaceutical Co., Ltd./Roche Holding AG’s Ronapreve (casirivimab/imdevimab; licensed from Regeneron Pharmaceuticals, Inc.) in July.  (Also see "Coronavirus Update: Japan Approves Antibody Cocktail In Short Order" - Scrip, 19 Jul, 2021.)

Sotrovimab (previously VIR-7831) has already been granted a US EUA and a positive opinion in the EU, along with an approval in Australia and temporary authorizations in a number of countries including Canada, Singapore and Italy.

Besides vaccines, a total of five drug or antibody treatments have now been approved in Japan under a Special Approval for Emergency system (the equivalent of an EUA), as provided for under Article 14-3 (Paragraph 1) of the Pharmaceuticals and Medical Devices Act. This enables rapid approvals for emergency public health needs if the products are already approved in countries with regulatory systems comparable to Japan’s.

Novavax/Serum Institute To Conduct Trials In Children Above Seven

Novavax, Inc.’s partner Serum Institute of India Pvt. Ltd. has got a recommendation from the Indian’s regulator’s Subject Expert Committee (SEC) to conduct Phase II/III clinical trials in children from seven to 11 years old.

It has submitted safety data for 100 volunteers from ongoing trials in the 12 to 17 years age group, based on which the SEC recommended an approval be granted by the Drugs Controller General of India’s The Central Drugs Standard Control Organisation.

Once the Matrix-adjuvanted recombinant protein vaccine candidate proves to be safe in the 7-11 age category, it could receive a nod for trials in an even younger age group. (Also see "COVID-19 Booster Study In Immunocompromised Patients Gives Novavax Another Shot On Goal" - Scrip, 26 Aug, 2021.)

Currently, Zydus Cadila’s COVID-19 vaccine Zy-CoV-D is the only one approved for those 12 and above. It’s expected to be launched in India on 2 October, media reports indicate. (Also see "Zydus Cadila Turns DNA Pioneer With COVID-19 Vaccine Approval" - Scrip, 24 Aug, 2021.)

In line with its stated intention to tie up with third party manufacturers, the company has roped in Shilpa Medicare Ltd’s wholly owned subsidiary, Shilpa Biologicals Pvt Ltd (SBPL) to make the drug substance for this DNA vaccine. SBPL will produce “mutually agreed” quantities at its Dharwad facility in Karnataka state.