“Authorizing these monoclonal antibody therapies can help ambulatory patients 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 a promising therapy early in life. their infection ”.
Regeneron’s antibody therapy is the second synthetic antibody therapy to receive Emergency Use Clearance (EUA) from the FDA after a similar therapy developed by Eli Lilly was granted status on November 9.
The human immune system naturally develops anti-infective proteins called antibodies – but not everyone gets an adequate response, companies like Regeneron and Lilly have made lab 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 came from a clinical trial involving 799 outpatients with mild to moderate symptoms of COVID-19.
For patients at high risk due to various underlying conditions – from obesity to old age to diabetes – hospitalization and emergency room visits occurred in 3% of patients who received intravenous therapy.
This compared to 9% in patients treated with placebo.
Patients treated with the drug also had lower remaining virus levels than placebo.80000 DOSES
The company said it expects to have doses ready for 80,000 patients by the end of November and for around 300,000 total patients by the end of January 2021.
These will be made available to US patients at no cost reimbursable under a US government program.
But with cases soaring in the United States 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 past two days alone.
The recommended dose is 1,200 milligrams of each of the two antibodies, for a total of 2,400 milligrams, as a single infusion.
Regeneron has received more than US $ 450 million from the US government for its COVID-19 drug development efforts as part of Operation Warp Speed.
So-called monoclonal antibodies are a relatively new class of drugs considered to be very promising.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after 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 altered to resemble that of a human. , the other of a human.
They then harvested the immune cells that made these antibodies and cultured them in a lab, to create a mass cure.
COVID-19 vaccines, like those developed by Pfizer and Moderna, work by causing the immune system to make its own antibodies so that they are prepared when they encounter the virus.