FDA grants emergency use authorization to COVID-19 antibody drug
The Food and Drug Administration (FDA) granted an emergency use authorization for a COVID-19 antibody drug made by GlaxoSmithKline (GSK).
Sotrovimab, an investigational monoclonal antibody therapy, has been authorized for treating mild to moderate COVID-19 in adults and pediatric patients aged 12 years and older who are at high risk for progressing to severe COVID-19, the FDA said in a statement.
The drug is not for patients who are hospitalized due to COVID-19 or those who require oxygen therapy.
GSK developed the drug with Vir Biotechnology.
The companies said in a separate statement that the treatment will be available for appropriate patients in the U.S. “in the coming weeks.” The companies further said they plan to file for full approval of the treatment “in the second half of 2021.”
GSK and Vir said the drug was shown to reduce the risk of hospitalization or death in high-risk adults by 85 percent in a trial of 868 patients.
The most common adverse events in the treatment group were rash and diarrhea, which were mild or moderate.
The company also said that data from lab studies shows that sotrovimab “maintains activity against all known circulating variants of concern,” though the clinical impact of the data is not yet known.
Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight off viruses.
Former President Trump praised an investigational monoclonal antibody made by Regeneron Pharmaceuticals that he was treated with when he contracted COVID-19 late last year. The FDA authorized that treatment in late November.
Another treatment from Eli Lilly has also been authorized by the FDA.