Regeneron Gets Emergency U.S. Clearance for Covid-19 Therapy

Regeneron Pharmaceuticals Inc.’s antibody cocktail received anemergency use authorization from U.S. drug regulators for treatment of early Covid-19 symptoms, adding to the expanding arsenal of therapies available to physicians.

The treatment, administered to President Donald Trump after he contracted the coronavirus in October, consists of two monoclonal antibodies that target the spike protein used by the virus to enter cells. Trump was treated with the drug based on a compassionate-use request by his doctors.

“In a clinical trial of patients with Covid-19, casirivimab and imdevimab, administered together, were shown to reduce Covid-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the U.S. Food and Drug Administration said in a statement on Saturday. “The safety and effectiveness of this investigational therapy for use in the treatment of Covid-19 continues to be evaluated.”

Trial findings released by Regeneron in October showed the drug may help treat patients outside the hospital, reducing virus levels and the need for further medical care. Earlier results, released in September, pushed Regeneron executives to reach out to the U.S. Food and Drug Administration about pursuing emergency-use authorization.

The issuance of an emergency-use authorization is different than an FDA approval, the agency said. Its decision comes as U.S. cases, hospitalizations and deaths all trend upward. A similar antibody therapy made by Eli Lilly & Co. received emergency clearance from the FDA on Nov. 9.

“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic,” Commissioner Stephen Hahn said in the statement. “Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system.”

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