Regeneron Pharmaceuticals’ antibody cocktail received an emergency use authorization from U.S. drug regulators on Saturday for the treatment of early symptoms of COVID-19.
With this, doctors have a new tool in the growing arsenal against the SARS-CoV-2 virus.
The treatment, Administered to President Donald Trump after he contracted COVID-19 in October, consists of two monoclonal antibodies that target the peak protein that the SARS-CoV-2 virus uses to enter cells.
Trump was treated with the drug based on a compassionate use request employed by his doctors.
“In a clinical trial of COVID-19 patients, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk of disease progression within 28 days after treatment compared to placebo, « the US Food and Drug Administration (FDA) said in a statement.
« The safety and efficacy of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated, » he added.
Trial results published by Regeneron in October showed that the drug can help treat patients outside of the hospital, reducing levels of the virus and the need for more medical care.
Previous results, published in September, prompted Regeneron executives to contact the FDA to request emergency use authorization.
An emergency use authorization is different from an FDA approval, the agency noted. His decision comes as cases, hospitalizations and deaths in the US are on the rise. A similar antibody therapy by Eli Lilly received emergency clearance from the FDA on November 9.
« The FDA remains committed to advancing the public health of the nation during this unprecedented pandemic, » Commissioner Stephen Hahn said in the statement.
« Licensing these monoclonal antibody therapies can help outpatients to avoid hospitalization and ease the burden on our healthcare system, « he said.
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