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The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy, an experimental treatment administered to President Donald Trump who said it helped him to cure him of the disease.
The FDA said on Saturday that the monoclonal antibodies, casirivimab and imdevimab, should be given together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who may develop severe COVID-19.
This includes those who are 65 or older or who have certain chronic medical conditions.
“Authorizing these monoclonal antibody therapies can help outpatients avoid hospitalization and ease the burden on our healthcare system,” said FDA commissioner Stephen Hahn.
The agency said antibodies are not allowed for patients hospitalized or in need of oxygen therapy due to the coronavirus.
Treatment with casirivimab and imdevimab have not been shown to be helpful in patients who need to be hospitalized due to COVID-19.
The emergency measure to proceed with its use is decided by evaluating the balance between the potential risks and benefits of the product in a critical situation, the FDA said. It’s not the same as FDA approval.
“Important step”
The agency said the data supporting Regeneron’s emergency use authorization comes from a clinical study of 799 outpatient patients with mild to moderate symptoms of COVID-19.
For patients at high risk due to a variety of underlying conditions – from obesity to old age to diabetes – hospitalization and emergency room visits occurred in three percent of patients who received intravenous treatment. This was compared with nine percent in placebo-treated patients.
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 in their life. infection”.
After the coronavirus attack and Trump’s treatment in October, he praised the antibody cocktail and said he wanted to get emergency approval for the drug.
“It wasn’t therapeutic for me – it just made me better, okay? I call it a cure, ”the president said.
“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, done 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 of charge by the government, but patients may have to pay the costs to healthcare facilities for administering the drug, the manufacturer said in a statement.
But with cases on the rise in the US and around the world, that means access won’t 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 Regeneron developed against the Ebola virus received full FDA approval, the next step after an emergency use authorization.
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 modified to be human-like, the other from a human.
They then collected the immune cells that made those antibodies and cultured them in the lab.
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.
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