GSK and Vir Biotechnology plan to launch Sotrovimab for treating COVID-19 in India :
GlaxoSmithKline (GSK), together with the US-based Vir Biotechnology, is planning to launch a single-dose mAb in India. This drug is called Sotrovimab (VIR-7831) and has received the EUA from the USFDA. It was approved for treating mild to moderate COVID-19 in high-risk adults and pediatric patients. 1
GSK India spokesperson stated that this drug was effective against the virus variant found in India. He also added that the pharma major was actively exploring all options to make this drug available to Indian patients soon.
Sotrovimab reduced the risk of hospitalization or death in high-risk adult outpatients by approximately 85%. This was obtained from the interim results of the Phase 3 trials in the US. This drug showed considerable activity against all known variants of the COVID-19 virus including the variant found in India.
GSK stated that this drug would be made available to the appropriate patients diagnosed with COVID-19 in the coming weeks. It also hopes to advance the approval of this drug in additional countries through discussions with other global regulators.
The pharma company also revealed that the DCGI could fast-track the clearance of the drug based on the data submitted. Sources also revealed that if the existing data is not enough, then limited trials can be conducted. These can substitute the time-consuming trials carried out in India for the approval of the drug.
Sotrovimab is administered intramuscularly in 500 mg doses. These antibodies are laboratory-made proteins that help to fight against harmful pathogens like viruses.
Preclinical data showed that this drug has the potential to block the viral entry into the cells and clear the infected cells. An interim analysis from 868 patients through day 15 has been used to demonstrate the safety of this drug. Of this, 430 patients were in the treatment arm while the remaining 438 belonged to the placebo arm.
Over 3 clinical trials are currently being carried out to prove Sotrovimab’s safety and efficacy. An infectious disease specialist has also asserted that Sotrovimab helps to avoid hospitalization in COVID-19 patients.
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