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Sotrovimab receives emergency use authorization to treat mild-to-moderate COVID-19

Sotrovimab receives emergency use authorization to treat mild-to-moderate COVID-19 Sotrovimab receives emergency use authorization to treat mild-to-moderate COVID-19
Sotrovimab receives emergency use authorization to treat mild-to-moderate COVID-19 Sotrovimab receives emergency use authorization to treat mild-to-moderate COVID-19

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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.

Source:

US-FDA

Article:

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

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