FDA authorises emergency use of experimental Covid drug given to Donald Trump

Grant Boone
November 23, 2020

The FDA has granted emergency use authorization for a second antibody treatment.

The US Food and Drug Administration on Saturday issued emergency use authorization 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 treatment is by USA biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together.

Clinical evidence from Regeneron's outpatient trials have suggested that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

"Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits".

This emergency use authorization (EUA) was for patients ages 12 and older who tested positive for SARS-CoV-2, as well as adults ages 65 and older with certain chronic medical conditions. Studies show Regeneron's REGN-COV2 reduced the amount of virus in the body and damage caused by it. Researchers hope the drug can keep patients from getting sicker and keep them out of the hospital.

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USA health officials have allowed the emergency use of a second antibody drug to help the immune system fight COVID-19.

The treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections. They bind to the coronavirus and prevent it from invading cells.

Regeneron has received more than US$500 million (S$672 million) from the federal government to develop and manufacture the treatments, a complex and time-consuming process.

"We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings". It is similar to a treatment by Eli Lilly company that obtained emergency approval by the FDA earlier this month.

Regeneron isn't the only company that's been working on antibody therapies for the coronavirus.

Neither drug has yet gotten full FDA approval, which entails much more rigorous reviews that take longer to complete.

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