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WASHINGTON: A COVID-19 antibody therapy used to treat President Donald Trump was approved by the US drug regulator on Saturday (November 21) for people who have not yet been hospitalized for the disease but who have a high risk.
The green light for drugmaker 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.
“Licensing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our health care system,” said Stephen Hahn, Commissioner of the Food and Drug Administration (FDA).
Leonard Schleifer, President and CEO 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 life. infection”.
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Regeneron’s antibody treatment is the second synthetic antibody treatment to receive an emergency use approval (US) 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 elicit an adequate response, companies like Regeneron and Lilly have manufactured laboratory-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 trial in 799 outpatients with mild to moderate symptoms of COVID-19.
For patients who were 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 percent of patients who received the IV treatment. .
This compared to 9 percent of placebo-treated patients.
Patients treated with the drug also had lower levels of the virus compared to those on placebo.
80,000 DOSES
The company said it expects to have doses ready for 80,000 patients by the end of November and around 300,000 patients in total by the end of January 2021.
These will be available to US patients at no out-of-pocket 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 will not be widespread. The United States has added more than 360,000 new cases of COVID-19 in the last 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 United States government for its COVID-19 drug development efforts under Operation Warp Speed.
The so-called monoclonal antibodies 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 a USA.
Comment: While the world awaits the coronavirus vaccine, antibody treatment is a necessary plan B
In the case of COVID-19, Regeneron first found two antibodies that were highly effective 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 harvested the immune cells that produced those antibodies and grew them in a lab to create a massive treatment.
COVID-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to produce its own antibodies so that they are ready when they encounter the virus.
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