A Covid-19 antibody therapy used to treat President Donald Trump was approved by the US Drug Enforcement Administration on Saturday for people who are not yet hospital-friendly but are at 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 hospital stays or emergency room visits in patients with underlying conditions.
“Authorizing these monoclonal antibody therapies can help outpatient clinics avoid hospital stays and alleviate the burden on our healthcare system,” said Stephen Hahn, Food and Drug Administration (FDA) commissioner.
Leonard Schleifer, Regeneron’s CEO and CEO, 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 treatment early in the 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 was granted status on 9 November.
The human immune system naturally develops anti-infective proteins called antibodies – but because not everyone has enough answers, companies like Regeneron and Lilly have developed laboratory 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 data supporting Regeneron’s EUA came from a clinical trial of 799 non-hospital patients 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 visits occurred in three percent of the patients who received the intravenous treatment.
This was compared with nine percent in placebo-treated patients.
Patients treated with the drug also had lower levels of the virus left than with 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 U.S. patients at no cost to them under the terms of a U.S. government program.
But with cases growing across the United States and globally, that means access will not be widespread. The United States has added more than 360,000 new Covid-19 cases in the last two days alone.
The recommended dose is 1200 mg of each of the two antibodies, a total of 2400 milligrams, in a single infusion.
Regeneron has received more than $ 450 million from the US government for its Covid-19 drug development efforts during Operation Warp Speed.
So-called monoclonal antibodies are a relatively new class of drugs that are seen as very promising.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after an EUA.
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, the other from a human.
They then harvested the immune cells that created these antibodies and cultured them in a laboratory to create a mass treatment.
Covid-19 vaccines, such as those developed by Pfizer and Moderna, work by training the immune system to create its own antibodies so that they are prepared when they encounter the virus.