The U.S. Food and Drug Administration has granted an emergency use authorization for a COVID-19 antibody drug made by GlaxoSmithKline (GSK,GSK.L) and Vir Biotechnology.
Sotrovimab, an investigational monoclonal antibody therapy, has been authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 years and older who are at high risk for progressing to severe COVID-19, including hospitalization or death, the FDA said in a statement on Wednesday.
The emergency use authorization allows for sotrovimab to be distributed and administered as a 500 milligram single dose intravenously by health care providers.
The FDA noted that the safety and effectiveness of the investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy.
According to the FDA, Laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the United Kingdom, South Africa, Brazil, California, New York and India.
GlaxoSmithKline and Vir stated that the treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial.
The companies said that they are working to make sotrovimab available to U.S. patients in the coming weeks. They are also working with government agencies around the world to make sotrovimab available to patients in need of treatment.
Meanwhile, Xencor Inc. (XNCR) said it previously entered into a technology license agreement with Vir Biotechnology, Inc., pursuant to which Vir has non-exclusive access to multiple Xencor Fc technologies, including Xtend Fc technology, designed to extend the half-life of novel antibodies that Vir is investigating as potential treatments for patients with COVID-19.
As per the terms of the agreement, Vir is solely responsible for the activities and costs related to research, development, regulatory and commercial activities for their COVID-19 drug candidates, and Xencor is eligible to receive royalties on net sales in the mid-single digit percent range.
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