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May 27, 2021Investigational Drug Sotrovimab Granted Emergency Use Authorization for Outpatient Treatment of COVID-19
May 26, 2021 – The U.S. FDA has granted emergency use authorization (EUA) to GlaxoSmithKline’s investigational monoclonal antibody sotrovimab to treat mild-to-moderate COVID-19. The drug is authorized for use in adults and pediatric patients (12 years of age and older weighing at least 40kg, or 88 pounds) who have tested positive for SARS-CoV-2 via direct viral testing and are at high risk of progression to severe COVID-19, including hospitalization or death.
An EUA does not represent full FDA approval. It is a mechanism by which the FDA can make treatments available in a public health emergency such as the COVID-19 pandemic when sufficient FDA-approved options are not available. Issuance of the EUA is based an interim analysis of data from a clinical trial in which sotrovimab reduced the risk of hospitalization or death by 85% compared to placebo. Dosing under the EUA is 500mg given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset as a single, 30-minute intravenous infusion.
A laboratory manufactured protein that mimics the human immune system, sotrovimab is specifically designed to work against the spike protein found on the outside of the SARS-CoV-2 virus. This allows it to block the virus from attaching to and entering human cells. According to the FDA, when used in the authorized population, sotrovimab’s known and potential benefits outweigh its known and potential risks.
Sotrovimab is not authorized for patients who are hospitalized for COVID-19 or require oxygen therapy due to COVID-19. The treatment has not shown benefit in patients hospitalized due to COVID-19. In addition, monoclonal antibodies may be associated with worse clinical outcomes when given to hospitalized patients who require high flow oxygen or mechanical ventilation.
A copy of the FDA’s announcement regarding sotrovimab’s EUA can be found on the agency’s website.>
The drug is available at a wholesale acquisition cost (WAC) of $2,100 per 500mg vial.