Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19.
The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency room visits for high-risk patients compared to placebo.
FDA has cleared the way for the monoclonal antibodies to be used for newly diagnosed SARS-COV-2 cases in high-risk patients.
The drug is not authorized for COVID-19 patients who are hospitalized or on oxygen therapy.
President Trump received the drug when hospitalized with COVID-19 in October.
The U.S. government will clear the way for some 300,000 patients to receive the drug cocktail at no charge under a U.S. government allocation program.
To qualify as “high risk” and thus be eligible for the drug, patients need to be either obese, over 65 or have a specified chronic disease (chronic kidney disease, diabetes or immunosuppressive disease). Patients over the age of 55 are also eligible if they have cardiovascular disease, hypertension or a chronic respiratory disease. Adolescents also qualify for the therapy under certain conditions.
Casirivimab and imdevimab are administered intravenously.
To date, more than 12.3 million people in the U.S. have been diagnosed with COVID-19, according to Johns Hopkins University.
In October, FDA approved Regeneron’s Inmazep, a mixture of three monoclonal antibodies, to treat Ebola.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
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