WASHINGTON: COVID-19 antibody therapy used to treat President Donald Trump was approved by the U.S. drug regulator on Saturday (Nov. 21) for people who are not yet hospitalized by the disease but at high risk.
The green light for drug maker Regeneron came after showing that REGEN-COV2, a combination of two laboratory-made antibodies, was decreasing in COVID-19-related hospitals or emergency room visits in patients with underlying conditions.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system,” said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).
Leonard Schleifer, president and CEO of Regeneron, added that the move is “an important step in the fight against COVID-19, as high-risk patients in the United States will access promising therapy early in the course of their infection” .
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Regeneron antibody treatment is the second synthetic antibody treatment to receive emergency use approval (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted the status on November 9.
The human immune system naturally develops infection-fighting proteins called antibodies – but because not everyone responds adequately, companies like Regeneron and Lilly have produced lab-made solutions.
They work by binding to surface protein from the SARS-CoV-2 virus and preventing it from invading human cells.
The FDA said the data supporting EUA Regeneron comes from a clinical trial in 799 non-hospitalized patients with mild to moderate symptoms of COVID-19.
For patients at high risk due to a variety of underlying conditions – from obesity to old age to diabetes – hospital visits and emergency rooms were undertaken in 3 per cent of patients who received the intravenous treatment.
This compared with 9 percent in patients treated with placebo.
Patients treated with the drug had lower levels of virus left over than those on the placebo.
The company said it expects to have doses ready for 80,000 patients ready by the end of November and about 300,000 patients in total by the end of January 2021.
These will be available to US patients at no cost out of pocket under the terms of the US government program.
But with cases rising across the US 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 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, in one infusion.
Regeneron has received more than US $ 450 million from the US government for its COVID-19 drug development efforts under Operation Warp Speed.
Monoclonal antibodies, as they are called, are a relatively new class of drug that is considered very promising.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after EUA.
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In the case of COVID-19, Regeneron found two antibodies that were highly effective against the SARS-CoV-2 virus, one of which the immune system was modified to be human-like, the other by human beings.
They then harvested the immune cells that made those antibodies and grew them in a laboratory, to create a mass treatment.
COVID-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so that they are ready when they encounter the virus.
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