FDA issues EUA for new COVID-19 treatment

On Saturday, FDA issued an emergency use authorization (EUA) for a combination monoclonal antibody treatment—casirivimab and imdevimab (Regeneron Pharmaceuticals)—to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients aged 12 years and older weighing 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. A clinical trial of patients with COVID-19 found that administering casirivimab and imdevimab together reduced COVID-19-related hospitalizations or emergency department visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo.

Casirivimab and imdevimab must be administered together by I.V. infusion. The drugs are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, in a press statement. “We will continue to facilitate the development, evaluation, and availability of COVID-19 therapies.”

Under the EUA, fact sheets that provide key information about using casirivimab and imdevimab administered together in treating COVID-19 as authorized must be made available to health care providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, and drug interactions.

This combination monoclonal antibody treatment is what was given to President Trump when he was first diagnosed with COVID-19.

The safety and effectiveness of this treatment for use against COVID-19 continues to be evaluated.