GlaxoSmithKline and Vir Biotechnology said final results from a late-stage study of their monoclonal antibody confirmed sotrovimab significantly reduced hospitalization and death among high-risk Covid-19 patients when given early in the disease.
The U.S. Food and Drug Administration gave an emergency use authorization to the antibody treatment developed by Vir Biotechnology and GlaxoSmithKline for treating mild-to-moderate Covid-19 in people aged 12 years and older.
The European Union’s drug regulator said on May 21 a Covid-19 antibody treatment developed by GlaxoSmithKline and Vir Biotechnology can be used to treat patients who are at risk of severe disease and do not need supplemental oxygen.
Europe’s medicines regulator said on May 7 the EMA has begun a real-time review of the Covid-19 antibody treatment developed by GSK and Vir Biotechnology,, formally kicking off the process for a potential European Union approval.
Antibody treatments from Eli Lilly and Vir Biotechnology reduced viral load in low-risk Covid-19 patients, results from a mid-stage trial showed on March 29.
GSK and Vir Biotechnology filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage Covid-19 infections, the drugmakers said on March 26.
Genentech reported that the company’s rheumatoid arthritis drug Actemra failed to hit the primary endpoint in a Covid-19 trial, while Vir and GlaxoSmithKline’s antibody against Covid-19 demonstrated 85 percent efficacy.
Vir Biotechnology and GlaxoSmithKline plan to seek emergency use authorization for their experimental Covid-19 antibody therapy after interim data from a study showed 85 percent reduction in hospitalization and deaths among patients.
Vir Biotechnology and Britain’s GlaxoSmithKline said on March 3 they would pause enrollment into a study testing their experimental Covid-19 antibody therapy, which is a part of a large U.S. trial.
Laboratory testing found that Regeneron Pharmaceuticals Inc.’s Covid-19 antibody cocktail can combat a coronavirus variant first found in South Africa, but a similar drug from Eli Lilly and Co. is inactive against it, according to a study.