Experimental Treatment Given to Trump Wins Approval

FDA clears Regeneron for emergency use against COVID
By Bob Cronin,  Newser Staff
Posted Nov 22, 2020 7:44 AM CST
Experimental Treatment Given to Trump Wins Approval
Scientists work last month with a bioreactor at a Regeneron facility in New York state on an experimental coronavirus antibody drug.   (Regeneron via AP)

Regeneron's experimental antibody treatment received emergency authorization on Saturday, clearing the way for patients to receive the same therapy given President Trump during his bout with COVID-19. The pharmaceutical company had told the Food and Drug Administration that trial data indicated that the treatment cut the number of medical visits needed by patients with mild or moderate illnesses, CNBC reports. REGN-COV2, a cocktail of two monoclonal antibodies, mimics the body's natural defenses before its immune response kicks in. The idea is to keep cases from becoming severe, per the Washington Post. "Antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," FDA Commissioner Stephen Hahn said in a statement, while research on the therapies continues.

Trump, who was given Regeneron's cocktail at Walter Reed hospital last month under a compassionate-use provision, said he considers it a cure for COVID-19. One of his Cabinet members, Ben Carson, also credits the treatment for his recovery. The treatment from Regeneron, and another by Eli Lilly cleared this month, can help reduce the toll of the disease before vaccines are widely available. But supplies will be short for a while, making decisions on who can get it an issue. Regeneron has estimated that doses for 80,000 patients will be ready by the end of this month, then 300,000 total doses by the end of January. It has not been approved for treating hospitalized patients, because it hasn't been shown to be effective at that point. Remdesivir, the antiviral drug from Gilead Sciences, is still the only COVID treatment to receive full approval for use in the US. (More coronavirus stories.)

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