Resource: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
Source: U.S. Food and Drug Administration
Synopsis: The FDA approved emergency use authorization for two antibody treatments to be used together during intravenous infusion. This is termed polyclonal antibody treatment. They include casirivimad and imdevimad. When administered together through intravenous infusion this drug combination known as Regeneron reduces COVID-19 related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Safety and efficacy continue to be evaluated. Regeneron is not indicated for patients who are hospitalized or who require oxygen therapy due to COVID-19 infection. Regeneron was given the emergency use authorization to be administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age or older and weighing at least 40 kg) with positive test results who are at high risk for progressing to severe COVID-19 infection. High-risk patients include those who are 65 years of age or older or who have certain chronic medical conditions.
Comment: Eli Lily was granted an emergency use authorization for intravenous antibody therapy. Now, the widely popularized polyclonal antibody therapy known as Regeneron has also been given emergency use authorization for treatment of COVID-19 infection. Regeneron consists of two antibodies known as casirivimad and imdevimab. These two “vimad” monoclonal antibodies attack the spike proteins of the coronavirus. By attacking the spike proteins on the coronavirus it greatly diminishes the entry of the virus into human cells. When used together they form a polyclonal antibody treatment known as Regeneron. It must be administered in a hospital setting.
