The US Food and Drug Administration (FDA) has authorized emergency use of Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy, an experimental treatment given to President Donald Trump, who he said helped cure him of the disease.
The FDA said Saturday that the monoclonal antibodies, casirivimab and imdevimab, should be co-administered to treat mild to moderate COVID-19 in adult and pediatric patients likely to develop a severe form of COVID-19.
This includes those who are 65 years or older or who have certain chronic medical conditions.
“Approval of these monoclonal antibody therapies can help outpatients avoid hospitalization and alleviate the burden on our healthcare system,”
The agency said the antibodies are not approved for patients who are hospitalized or in need of oxygen therapy due to coronavirus.
Casirivimab and imdevimab treatment have not been shown to be beneficial in patients admitted due to COVID-19.
The emergency measure to proceed with use is determined by evaluating the balance between potential risks and benefits of the product in a critical situation, as the FDA said. It’s not the same as FDA approval.
The agency said the data supporting Regeneron’s authorization for acute use came from a clinical trial of 799 inpatients with mild to moderate symptoms of COVID-19.
For patients at high risk due to a range of underlying conditions – from obesity to old age to diabetes – hospitalization and emergency room visits occurred in three percent of the patients who received the intravenous treatment. This was compared to nine percent in placebo-treated patients.
Leonard Schleifer, Regeneron’s president and CEO, said FDA approval 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 course of their infection.”
After Trump’s coronavirus attack and treatment in October, he praised the antibody cocktail and said he wanted to get emergency approval of the drug.
“For me it was not therapeutic – it just made me better, OK? I call it a cure, ”the president said.
“I will pick up what I have got for you and I will do it for free,” he said, adding that there were “hundreds of thousands of doses almost ready.”
A similar antibody treatment, conducted by Eli Lilly, also received emergency approval earlier this month.
According to the New York Times, Regeneron has received more than $ 500 million. From the US government to developing the treatments.
The first 300,000 doses will be provided free of charge by the government, but patients may have to pay for healthcare facilities to have the medicine administered, the drugmaker said in a statement.
But with cases rising 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.
Last month, an antibody drug developed by Regeneron against the Ebola virus received full FDA approval, the next step after an emergency use approval.
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 produced these antibodies and cultured them in a laboratory.
COVID-19 vaccines, such as those developed by Pfizer and Moderna, work by training the immune system to make its own antibodies so that they are prepared when they encounter the virus.