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WASHINGTON – A COVID-19 antibody therapy used to treat US President Donald Trump was approved Saturday by the US drug regulator for people who are not yet hospitalized from the disease but are at high risk.
The green light for drug maker Regeneron came after REGEN-COV2, a combination of two laboratory-made antibodies, was shown to reduce COVID-19-related hospitalizations or emergency room visits in patients with underlying conditions.
“Authorizing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our healthcare system,” said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).
Leonard Schleifer, president and chief executive officer of Regeneron, added that the move was “an important step in the fight against COVID-19, as high-risk patients in the United States will have access to promising therapy in the early stages of their infection. “.
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 gained status on November 9.
The human immune system naturally develops infection-fighting proteins called antibodies, but because not all of them provide an adequate response, companies like Regeneron and Lilly have produced lab-made solutions.
They work by binding to a surface protein of the SARS-CoV-2 virus and preventing it from invading human cells.
The FDA said the data supporting Regeneron’s EUA comes from a clinical study of 799 outpatient 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 – hospitalization and emergency room visits occurred in 3% of patients who received intravenous treatment.
This compared to nine percent in placebo-treated patients.
Patients treated with the drug also had lower levels of virus remaining than those on placebo.
80,000 DOSES
The company said it expects to have ready doses 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 additional cost under the terms of a US government program.
But with cases on the rise in the US and around the world, that means access won’t be widespread. The United States has added more than 360,000 new cases of COVID-19 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 a single infusion.
Regeneron has received more than $ 450 million from the US government for its COVID-19 drug development efforts under Operation Warp Speed.
So-called monoclonal antibodies are a relatively new drug class that is considered to be highly promising.
Last month, an antibody drug Regeneron developed against the Ebola virus received full FDA approval, the next step after an EUA.
In the case of COVID-19, Regeneron first found two highly effective antibodies against the SARS-CoV-2 virus, one from a mouse whose immune system was modified to be human-like, the other from a human.
They then collected the immune cells that produced those antibodies and cultured them in the lab, in order to create a mass treatment.
COVID-19 vaccines, such as those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so that they are prepared when they encounter the virus.
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