FDA Issues EUA to GSK for COVID-19 Treatment Sotrovimab

Sotrovimab is authorized to treat COVID-19 patients 12 years of age and older with mild-to-moderate infection and who are at high risk for severe disease progression.

The FDA has issued an emergency use authorization (EUA) to GlaxoSmithKline (GSK) for sotrovimab for the treatment of mild-to-moderate COVID-19.1

The authorization permits treatment with sotrovimab in both adult and pediatric patients 12 years older and weighing at least 88 pounds with positive SARS-CoV-2 test results who are at high risk for contracting severe COVID-19, including hospitalization or death.1

Sotrovimab is a recombinant human immunoglobulin G1K monoclonal antibody that binds to the spike protein receptor of SARS-CoV-2 and blocks viral attachment and entry into human cells.1,2 The latest COVID-19 treatment will be administered intravenously as a 50- mg single dose. According to Denise M. Hinton, chief scientist at the FDA and author of the authorization letter to GSK, unopened vials of sotrovimab should be stored in refrigerated conditions (36°F to 46°F) and opened, diluted sotrovimab vials should be administered within 24 hours if kept at refrigerated temperatures and within 4 hours if kept at room temperature, including transportation and infusion time.

The FDA’s decision is based on review of the interim analysis of phase 1/2/3 data from the randomized, double-blind, placebo-controlled COMET-ICE clinical trial that evaluated the safety and efficacy of sotrovimab 500 mg in outpatients.2 The study incorporated 583 non-hospitalized adults with mild-to-moderate COVID-19 and a positive SARS-CoV-2 test. Participants were randomized to receive either sotrovimab (n=291) or placebo (n=292) within 5 days of symptom onset. Investigators demarcated a primary end point of COVID-19 progression, defined as hospitalization for more than 24 hours for acute management of any illness, or death from any cause, through day 29. Hospitalization or death occurred in 21 (7%) patients who received placebo and 3 (1%) patients who received sotrovimab, indicating an 85% reduction.

In addition, investigators reported that sotrovimab held up against SARS-CoV-2 variants from the United Kingdom, South Africa, Brazil, California, New York, and India.

The treatment is not for use in patients who have been hospitalized due to COVID-19, nor is it authorized for individuals requiring oxygen therapy for a SARS-CoV-2 infection. Only health care settings with immediate access to medications for anaphylaxis and the ability to activate the emergency medical system can administer sotrovimab treatment. Potential adverse effects include anaphylaxis and infusion-related reactions, as well as rash and diarrhea.1

“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, MD, director of the FDA’s Center for Drug Evaluation and Research.1 “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.” 

Health care professionals who will be administering sotrovimab under the EUA are encouraged to review the FDA fact sheet.

References

  1. Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19. News Release. FDA; May 26, 2021. Accessed May 27, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19.
  2. Hinton DM. Emergency Use Authorization 100. FDA; May 26, 2021. Accessed May 27, 2021. https://www.fda.gov/media/149532/download.