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New Covid-19 drug gets US clearance; GSK plans rollout in India

New Covid-19 drug gets US clearance; GSK plans rollout in India

Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the US in the coming weeks and discussions with global regulators regarding authorisations in additional countries continue to advance, said GSK

Global pharma major GlaxoSmithKline and US-based Vir Biotechnology are planning to launch Sotrovimab (VIR-7831), a drug which has received Emergency Use Authorisation (EUA) from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and pediatric patients, in India.

"It is found to be effective against the virus variant found in India and we are exploring all options to quickly make this important medicine available for Indian patients," said a GSK India spokesperson.

Treatment with Sotrovimab showed an 85% reduction in the risk of hospitalisation or death in high-risk adult  outpatients, based on interim results from Phase 3 trials in the US. The drug was found to act against all known variants of concern, including the variant from India.

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Sotrovimab will be available for appropriate patients diagnosed with COVID-19 in the US in the coming weeks and discussions with global regulators regarding authorisations in additional countries continue to advance, said GSK. Sources said the DCGI can fast track clearance for the drug, based on data submitted by GSK-Vir or with limited trials, rather than insisting on time-consuming Indian trials to approve the drug.

GSK said Sotrovimab is a single-dose monoclonal antibody, which will be administered in 500 mg instramuscular. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses.

Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The safety of Sotrovimab is primarily based on an interim analysis from 868 patients (430 patients in the treatment arm and 438 in the placebo arm) through day 15. At least three trials are being done to prove its safety and efficacy.

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"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," said Dr Hal Barron, Chief Scientific Officer and President R&D, GSK.

"Monoclonal antibodies like Sotrovimab are potentially one of our most effective tools for fighting COVID-19. While preventive measures, including vaccines, can reduce the total number of cases, Sotrovimab is an important treatment option for those who become ill with COVID-19 and are at high risk - allowing them to avoid hospitalisation or worse," said Adrienne E. Shapiro, M.D., Ph.D., an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the clinical trials.

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