Britain’s GlaxoSmithKline (GSK) and Nasdaq-listed Vir Biotechnology have won the US drug regulator’s approval for a drug to treat mild and moderate Covid-19 patients older than 12.
A spokesperson for GSK India said that the company was exploring options to make Sotrovimab, an “important medicine”, available for Indian patients quickly. The spokesperson did not comment on possible pricing of the product that will be available in the US in weeks. “Discussions with global regulators regarding authorisations in additional countries continue to advance,” GSK said.
Cipla recently launched its Roche antibody cocktail (casrivimab and imdevimab) for Rs 60,000 per patient for Covid-19 treatment in India.
Treatment with Sotrovimab resulted in an 85 per cent reduction in the risk of hospitalisation or death in high-risk adult Covid-19 outpatients compared to a placebo, interim results from a Phase 3 trial showed. Data indicates Sotrovimab helps against all known variants of the virus, including the B.1.617 strain first found in India.
The antibody therapy is not recommended for hospitalised Covid-19 patients. USA’s Food and Drug Administration (USFDA) said on its website, “The safety and effectiveness of this 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 due to COVID-19.”
It added that this treatment has not shown benefit in patients hospitalized due to Covid-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.
“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.
GSK’s President R&D and chief scientific officer Hal Barron said there is a need to help prevent infected patients from developing further 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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