The USFDA had issued an emergency use authorization for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. It is approved for use in COVID-19 positive patients who are 12 years and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19/ hospitalization. Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. This emergency approval is based on an interim analysis from phase two randomized, placebo-controlled, double-blind clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms. Most patients, including those receiving placebo, cleared the virus by day 11.
However, for patients at high risk of disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab treated patients on average compared to 10% in placebo. The emergency approval allows for bamlanivimab to be distributed and administered as a single dose IV by health care providers.
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