FDA Allows Emergency Use Of Antibody Drug Trump Received

Modesto Morganelli
Novembre 22, 2020

The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease.

When Trump had Covid-19 last month, he received Regeneron's experimental antibody treatment, which is still in large-scale clinical trials but has been available for compassionate use - something the FDA has to approve on an individual basis, as it did for the President.

The treatment is by USA biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together.

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.

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. Patients with other conditions like diabetes, cardiovascular disease or chronic kidney disease also qualify for the drug.

Regeneron's antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.

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

There are several monoclonal antibody treatments that are in the experimental phase of testing and have not been given an emergency use authorization by the FDA.

But with cases surging across the U.S. and globally, that means access will not be widespread. The US has added more than 360,000 new Covid-19 cases in the past two days alone. 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.

They then harvested the immune cells that made those antibodies and grew them in a lab, in order to create a mass treatment.

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