(Alliance News) - GlaxoSmithKline PLC and Vir Biotechnology Inc on Wednesday said the US Food & Drug Administration granted an emergency use authorization for sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate Covid-19.
The Brentford, England-based pharmaceutical company said treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalisation or death in high-risk adult outpatients compared to placebo, based on interim results from phase 3 Comet-Ice trial.
Sotrovimab is continuing to be studied in ongoing clinical trials, GSK said. An analysis of safety and efficacy data at day 29 for the full population from the Comet-Ice trial is expected as early as in the first half of 2021.
GSK and Vir plan to submit a biologics license application to the US FDA in the second half of 2021.
"I believe that sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially for future coronavirus outbreaks, as well," said George Scangos, chief executive of Vir.
"In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need," added Hal Barron, chief scientific officer & president of research & development at GSK.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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Glaxosmithkline (GSK)