Regeneron Gets Emergency US Clearance for COVID-19 Therapy

Ben Carson Says He Was 'Desperately Ill' With The Coronavirus

The recommended dose is a total of 2,400 milligrams having 1,200 milligrams of each antibody in a single infusion.The treatment is expected to help at a time when COVID-19 cases have surged significantly in the United States.

Dr. Ben Carson, the secretary of Housing and Urban Development, credited President Donald Trump for his recovery from coronavirus after the president approved Carson to receive experimental treatment.

Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need".

The issuance of an emergency-use authorization is different than an FDA approval, the agency said.

Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.

For patients who were at high risk because of a variety of underlying conditions - from obesity to old age to diabetes - hospitalization and emergency room visits occurred in three percent of patients who received the intravenous treatment.

Patients treated with the drug also had lower levels of virus remaining compared to those on the placebo.

Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. To be sure, after any infection, the human immune system has the tendency to respond naturally against the infection, thus releasing antibodies.

The antibodies target the spike protein the virus uses to drill into healthy cells.

The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective.

"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic".

Regeneron isn't the only company that's been working on antibody therapies for the coronavirus.

"REGEN-COV2 is created to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus", said Dr George D Yancopoulos, President and Chief Scientific Officer of Regeneron.

The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms.

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