GSK and Vir Biotechnology on May 26 announced that USFDA granted Emergency Use Authorisation (EUA) of Sotrovimab (previously VIR-7831), for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients
Treatment with Sotrovimab resulted in an 85 percent reduction in the risk of hospitalisation or death in high-risk adult COVID-19 outpatients compared to placebo, based on interim results from the Phase 3 COMET-ICE trial.
GlaxoSmithKline (GSK) said it plans to make monoclonal antibody Sotrovimab available in India quickly.
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In vitro data indicate Sotrovimab maintains activity against all known variants of concern, including variant B.1.617 from India.
“We are exploring all options to quickly make this important medicine available for Indian patients ” GSK India spokesperson told Moneycontrol.
GSK said it is in discussions with global regulators regarding authorisations in additional countries that continue to advance.
“Our distinctive scientific approach has led to a single monoclonal antibody that, based on an interim analysis, resulted in an 85 percent reduction in all-cause hospitalisations or death, and has demonstrated, in vitro, that it retains activity against all known variants of concern, including the emerging variant from India," said George Scangos, Chief Executive Officer of Vir.
"I believe that Sotrovimab is a critical new treatment option in the fight against the current pandemic and potentially," Scangos added.
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said the fast pace of COVID-19 vaccinations in the US is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications.
"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 for future coronavirus outbreaks," Barron said.
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