FDA grants emergency use authorization for GSK’s COVID-19 treatment

The Food and Drug Administration has issued an emergency use authorization for GlaxoSmithKline’s investigational monoclonal antibody therapy Sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.

The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. This treatment has not shown benefit in patients hospitalized due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.

"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," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "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."

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as 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 authorization allows for sotrovimab to be distributed and administered as a 500-mg single dose intravenously by health care providers. The EUA requires that fact sheets that provide important information about using sotrovimab in treating COVID-19 be made available to health care providers and to patients, parents and caregivers, including dosing instructions, potential side effects and drug interactions. Potential side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhea.