FDA Authorizes Additional Monoclonal Antibody for Treatment
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 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.

The data supporting this EUA for sotrovimab are based on an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Of these patients, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 through day 29. Hospitalization or death occurred in 21 (7%) patients who received placebo compared to 3 (1%) patients treated with sotrovimab, an 85% reduction.

The FDA is carefully monitoring circulating viral variants and their sensitivity to monoclonal antibodies authorized to treat COVID-19, including sotrovimab. Laboratory testing showed that sotrovimab retains activity against the current circulating variants first reported in the United Kingdom, South Africa, Brazil, California, New York and India. The EUA allows for sotrovimab to be distributed and administered as a 500 milligram 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.

Source:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19
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