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FDA grants emergency use authorization to sotrovimab for
managing patients having mild-to-moderate COVID-19.
As per the notification on 26 May 2021, sotrovimab was granted emergency use authorization by United States Food and Drug Administration (US-FDA) to treat mild-to-moderate COVID-19 in adults and pediatrics (age 12 years and older, weight at least 40 kilograms [about 88 pounds]) who are at elevated risk for advancement to severe COVID-19, including mortality or hospitalization (such as people having specific medical conditions or people who are 65 years of age and above).
Sotrovimab, an investigational monoclonal antibody, is specifically directed against the spike protein of coronavirus and is designed to inhibit the attachment and entrance of virus into the host cells. Sotrovimab is not approved for individuals who are hospitalized or need oxygen due to coronavirus infection.
The EUA was granted on the basis of data from an interim analysis from a placebo-controlled, randomized, double-blind trial. This phase 1/2/3 trial recruited 583 non-hospitalized adults having COVID-19 symptoms and a positive SARS-CoV-2 test result. Participants were segregated to receive sotrovimab (n=291) or placebo (n=292) within five days of onset of coronavirus symptoms.
Advancement of coronavirus infection (defined as hospitalization for more than 24 hours for acute treatment of any illness or mortality from any cause) through day 29 was the major outcome parameter. Hospitalization or death occurred in less number of patients receiving sotrovimab in comparison with patients receiving placebo (85% decline), as shown in Table 1:
The USFDA is meticulously supervising the circulating viral variants and their sensitivity to monoclonal antibodies approved to combat coronavirus infection, including sotrovimab. The lab testing demonstrated that sotrovimab retains activity against the current circulating variants initially reported in India, California, United Kingdom, New York, South Africa, and Brazil.
The EUA permits sotrovimab to be
distributed and administered as an intravenous administration of 500 milligrams
single dose by medical care providers. Diarrhea, rash, anaphylaxis, and
infusion-related reactions are the commonly reported side effects of
sotrovimab.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
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