The US Food and Drug Administration (FDA) has granted emergency-use authorisation for Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy, an experimental treatment given to President Donald Trump that he said helped cure him of the disease.
The FDA said on Saturday that the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are likely to develop a severe form of COVID-19.
This includes those who are 65 years of age or older or who have certain chronic medical conditions.
“Authorising these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said Stephen Hahn, commissioner of the FDA.
The agency said the antibodies are not authorised for patients who are hospitalised or require oxygen therapy due to the coronavirus.
Casirivimab and imdevimab treatment has not been shown to be beneficial in patients who have to be hospitalised due to COVID-19.
The emergency measure to go ahead with its use is decided by evaluating the balance of potential risks and benefits of the product in a critical situation the FDA said. It is not the same as FDA approval.
‘Important step’
The agency said the data supporting Regeneron’s emergency use authorisation came from a clinical trial in 799 non-hospitalised patients with mild to moderate symptoms of COVID-19.
For patients who were at high risk because of a variety of underlying conditions – from obesity to old age to diabetes – hospitalisation and emergency room visits occurred in three percent of patients who received the intravenous treatment. This was compared to nine percent in placebo-treated patients.
Leonard Schleifer, Regeneron’s president and CEO, said the FDA authorisation 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 the course of their infection”.
After Trump’s bout of coronavirus and treatment in October, he praised the antibody cocktail and said he wanted to get emergency approval for the drug.
“To me it wasn’t therapeutic – it just made me better, OK? I call that a cure,” the president said.
“I want to get for you what I got and I’m gonna make it free,” he said, adding there were “hundreds of thousands of doses that are just about ready”.
A similar antibody treatment, made by Eli Lilly, was also given emergency approval earlier this month.
Regeneron has received more than $500m from the US government to develop the treatments, according to the New York Times newspaper.
The first 300,000 doses will be provided free of charge by the government but patients may have to pay costs to health facilities to have the medication administered, the drugmaker said in a statement.
But with cases surging 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.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after an emergency use authorisation.
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 made those antibodies and grew them in a lab.
COVID-19 vaccines, like those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so they are prepared when they encounter the virus.
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