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COVID-19: FDA authorises Regeneron antibody drug given to Trump | US & Canada

US agency grants emergency-use authorisation for the experimental antibody treatment used to treat President Donald Trump.

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 US 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.

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.

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”.

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.

A similar treatment, made by Eli Lilly, was also given emergency approval earlier this month.

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