FDA Allows Emergency Use Of Antibody Drug Trump Received

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Regeneron Pharmaceuticals Inc.'s antibody cocktail received an emergency use authorization from us drug regulators for treatment of early COVID-19 symptoms, adding to the expanding arsenal of therapies available to physicians.

The drug company, which started clinical trials on June 11, said that preliminary results from a trial reveal that its antibody treatment could reduce the severity of the virus in non-hospitalised patients with Covid-19.

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.

"The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated".

"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system", said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).

The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

After Trump received the Regeneron treatment when he was infected with Covid-19, he touted it as a virtual "cure" for the illness, promising to make it free for Americans.

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The treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.

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

The company said it expects to have doses ready for 80,000 patients ready by the end of November and approximately 300,000 patients in total by the end of January 2021.

These will be available to U.S. patients at no out-of-pocket cost under the terms of a USA government program.

The news comes amid a surge of coronavirus infections across the country, with daily cases soaring to record highs.

Regeneron is still awaiting emergency use authorization.

Regeneron has received more than $500 million from the United States government to develop and manufacture the treatments, according to The New York Times.

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