The United States Food and Drug Administration (FDA) has granted emergency use authorization for the COVID-19 antibody treatment from Regeneron Pharmaceuticals Inc., an experimental treatment administered to President Donald Trump who it says l ‘helped cure 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 at risk of developing a severe form of COVID-19.
This includes people who are 65 years of age or older or who have certain chronic conditions.
“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 FDA.
The agency said the antibodies are not allowed for patients in hospital or requiring oxygen therapy due to the coronavirus.
Treatment with casirivimab and imdevimab has not been shown to benefit in patients requiring hospitalization due to COVID-19.
The emergency measure to go ahead with its use is decided by weighing 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.
The agency said the data supporting the emergency use authorization of Regeneron came from a clinical trial involving 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% of patients who received treatment intravenous. This was compared to nine percent in patients treated with placebo.
Leonard Schleifer, president and CEO of Regeneron, said the FDA clearance was “an important step in the fight against COVID-19, as high-risk patients in the United States will have access to promising therapy early on. of their infection ”.
After Trump’s coronavirus and treatment episode in October, he praised the cocktail of antibodies and said he wanted emergency approval for the drug.
“For me it wasn’t therapeutic – it just made me better, okay?” I call it a cure, ”said the president.
“I want to get what I have for you and I will make it free,” he said, adding that there were “hundreds of thousands of doses that are almost ready.”
A similar antibody treatment, made by Eli Lilly, also received emergency approval earlier this month.
Regeneron has received more than $ 500 million from the US government to develop the treatments, according to the New York Times newspaper.
The first 300,000 doses will be provided free by the government, but patients may have to pay a fee to healthcare facilities for the drug to be administered, the drugmaker said in a statement.
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.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after emergency use clearance.
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 humans, the other of a human.
They then harvested the immune cells that made these antibodies and cultured them in a lab.
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.