The U.S. Food and Drug Administration (FDA) has granted emergency use authorization to a monoclonal antibody drug developed by GlaxoSmithKline (GSK) in partnership with Vir Biotechnology.
The FDA approved Sotroimab for treating mild to moderate COVID-19 in adults and pediatric patients aged 12 and older who are at a heightened risk of having a severe case of the virus. The drug isn’t for hospitalized patients or those who require oxygen therapy.
“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
Reduces risk of severe symptoms
In a trial involving 868 adults, the monoclonal antibody drug was shown to cut the risk of hospitalization or death in “high-risk” adults by 85%. Adverse events were generally mild or moderate and included rash and diarrhea.
In a separate statement, GSK and Vir said sotrovimab will be available for the patients that it’s intended to help “in the coming weeks.” The companies said they plan to file for full approval of the drug sometime in the second half of this year.
Antibody treatments garnered attention following former President Donald Trump’s contraction of COVID-19 and use of the drugs. Monoclonal antibodies are designed in a laboratory to replicate the immune system’s ability to fight viruses.
“Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells,” the FDA explained.
Eli Lilly has also received FDA authorization for an antibody therapy that significantly reduces the risk of hospitalization as a result of COVID-19.