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GlaxoSmithKline and Vir Biotechnology have said that their investigational monoclonal antibody Sotrovimab was effective against all mutations of the Omicron variant of SARS-CoV-2 virus, according to early studies.
The preclinical data was generated through pseudo-virus testing of the combined known mutations of the Omicron variant, which included the maximum number of changes (37 mutations) identified to date in the spike protein, a note from the companies said.
Also see: Vaccination continues at brisk pace in 18-45 age group
George Scangos, CEO, Vir, said that Sotrovimab was the first monoclonal antibody to report preclinical data demonstrating activity against all tested SARS-CoV-2 variants of concern and interest to date, including Omicron, as well as the still prevalent and highly contagious Delta variant.
Early treatment
“Given the less than three-fold neutralisation shift demonstrated in the pre-clinical pseudo-virus assay, which falls below the FDA authorised fact sheet guidance of less than a 5-fold change, we are confident that Sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of Covid-19,” he said.
Dr Hal Barron, GSK Chief Scientific Officer and President R&D, added that the pre-clinical data demonstrated the potential for the monoclonal antibody to be effective against Omicron and all other variants of concern defined to date by the WHO.
Conditional authorisations
Sotrovimab is presently authorised for emergency use in the United States. It has been given conditional marketing authorisation by the UK Medicines and Healthcare Products Regulatory Agency, provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia. It has also been approved via the special approval for emergency pathway in Japan., the companies said, adding that temporary authorisations has been granted in a dozen other countries.
Also see: Nearly all cases of Omicron Covid variant in Delhi and Rajasthan are asymptomatic
The drug is supplied in several countries including through national agreements in the United States, United Kingdom, Japan, Australia, Canada, Singapore, Switzerland, and the United Arab Emirates. The companies have signed a Joint Procurement Agreement with the European Commission to supply doses of Sotrovimab.
GSK and Vir are also partnering to assess the use of Sotrovimab in uninfected immunocompromised adults to determine whether it can prevent symptomatic Covid-19 infection.
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