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

Bloomberg logoBloomberg 11/22/2020 Robert Langreth and Angelica LaVito
a sign on the side of a building: Regeneron Pharmaceuticals Inc. signage is displayed outside their headquarters in Tarrytown, N.Y., U.S., on June 12, 2020. Regeneron Pharmaceuticals Inc. said it had begun human trials of a new antibody cocktail for Covid-19, part of an ambitious clinical-testing plan that could lead to a new treatment option by the end of summer if all goes well. © Bloomberg Regeneron Pharmaceuticals Inc. signage is displayed outside their headquarters in Tarrytown, N.Y., U.S., on June 12, 2020. Regeneron Pharmaceuticals Inc. said it had begun human trials of a new antibody cocktail for Covid-19, part of an ambitious clinical-testing plan that could lead to a new treatment option by the end of summer if all goes well.

(Bloomberg) -- Regeneron Pharmaceuticals Inc.’s antibody cocktail received an emergency-use authorization from U.S. drug regulators for treatment of early Covid-19 symptoms, adding to the expanding arsenal of therapies available to physicians at a time when the virus is surging.

Regeneron’s treatment was given to President Donald Trump last month after he contracted Covid-19. While Trump received a number of drugs to combat the virus, he said after he was released from the hospital he expected speedy authorization of Regeneron’s therapy, crediting it with his recovery.

The company said in a statement on Saturday that its therapy, called REGN-COV2, had been authorized for the treatment of mild to moderate Covid-19 in adults and some children of at least 12 years of age. A similar antibody therapy made by Eli Lilly & Co. received emergency clearance from the FDA on Nov. 9.

The FDA’s decision comes as U.S. cases, hospitalizations and deaths all trend upward, and as other drugmakers race to win emergency clearance for experimental vaccines. New cases in the U.S. have topped 100,000 each day since Nov. 5., and on Saturday surpassed 12 million since the start of the pandemic.

“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.”

While antibody therapies have been hailed by U.S. infectious-disease chief Anthony Fauci and others as a potential bridge to a vaccine, their emergency clearance comes at a time when the spike in cases and a strained virus-testing system are running up against what is expected to be a limited supply of the therapies.

Regeneron said in its statement Saturday it expects to have treatment doses ready for approximately 80,000 patients by the end of this month, about 200,000 patients by the first week of January, and about 300,000 patients total by the end of January.

The cocktail treatment consists of two monoclonal antibodies that target the spike protein used by the virus to enter cells. Trial findings released by the company in October showed that the drug may help treat patients outside the hospital, reducing virus levels and the need for further medical care.

The therapy appeared to be most beneficial in the subset of patients who hadn’t yet produced coronavirus antibodies on their own, the company has said.

Regeneron, based in Tarrytown, New York, has clinched a $450 million supply deal from Operation Warp Speed, the U.S. government’s program to accelerate vaccines and treatments for Covid-19. The company has said it will make its therapy available at no cost to patients.

(Updates with U.S. cases in fourth paragraph)

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