FDA authorises emergency use of experimental Covid drug given to Donald Trump

Cheryl Sanders
November 22, 2020

"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).

In September, Regeneron announced it is to create an additional 400 jobs in Limerick to allow it to maximise manufacturing capacity at its NY facility for its Covid-19 antibody drug combination REGN-COV2.

Dr George D Yancopoulos, Regeneron's president and chief scientific officer, said in a statement that he was encouraged by the recent vaccine results, but "there remains a need to treat patients who develop Covid-19, especially as some may not have had access to or were not protected by vaccination". The FDA's review determined that it is reasonable to believe that casirivimab and imdevimab administered together may be effective in treating patients with mild or moderate COVID-19. "The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated".

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The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35.

Regeneron is set to have doses ready for 80,000 patients by the end of this month and come January 2021, around 3 lakh patients can be given doses for these.

This compared to nine percent in placebo-treated patients. Patients with other conditions like diabetes, cardiovascular disease or chronic kidney disease also qualify for the drug.

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

As TheBlaze reported, Carson contracted COVID-19 about two weeks ago.

An emergency use of authorizations is different than an FDA approval.

The US has now more than 12 million confirmed Covid-19 infections, with more than 255,000 deaths, according to data compiled by Johns Hopkins University. Monoclonal antibodies, such as casirivimab and imdevimab, could lead to worse outcomes for hospitalized patients requiring high flow oxygen or mechanical ventilation, the FDA said.

They then harvested the immune cells that made those antibodies and grew them in a lab, in order to create a mass treatment. Antibodies are proteins that the body produces to fight off infection and diseases.

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