GSK and Vir Biotechnology said Friday that their Covid-19 drug candidate VIR-7831 has received emergency use authorization (EUA) from the U.S. Food and Drug Administration. 

FDA granted the EUA for the single monoclonal antibody candidate developed by GSK and Vir to treat and prevent mild and moderate Covid-19 patients aged 12 or more and weighing at least 40 kg from advancing to a severe state where the virus could kill the infected.

"Monoclonal antibodies, including sotrovimab, are one of the most effective drugs in combating Covid-19," said Dr. Adrienne Shapiro of Fred Hutchinson Cancer Research Center who participated in phase 3 COMET-ICE study. "If the preventive measures, such as vaccines, could reduce the number of infections, sotrovimab could be a significant option to prevent infected people from developing into a severe condition in which they require hospitalization or even worse."

Vir Biotechnology CEO George Scangos said, "We have discovered a monoclonal antibody that could reduce hospitalization or death by 85 percent in the interim results, and the drug candidate also maintained the activity against the variant of concerns, including one originated from India."

Scangos added that he believes sotrovimab to be an important option for treating the Covid-19 pandemic and emerging Covid-19 in the future.

GSK Chief Scientific Officer Dr. Hal Barron also said. "The rapidly increasing number of vaccinated people is quite encouraging, but we still need some measures for complications among the already infected people. We are pleased to offer the benefits of the unique monoclonal antibody to patients in need."

The two partners continue their studies of sotrovimab, and the COMET-ICE study results of the safety and efficacy of using the drug for 29 days would be released in the first half of 2021.

GSK and Vir plan to submit a biologics license application (BLA) to FDA in the second half-year.