Regeneron Asks FDA for Emergency Use Authorization of Coronavirus Therapy Used to Treat President Trump | Health News

Regeneron announced Wednesday night that it has asked the Food and Drug Administration for emergency use authorization for the experimental coronavirus antibody therapy used to treat President Donald Trump after he tested positive for the virus.

The biotechnology company said in a statement that it made that emergency use request for its REGN-COV2 investigational antibody combination for COVID-19. If the emergency authorization is granted, the government has committed to making it available to Americans at no cost and would be responsible for its distribution, the statement said.

Enough doses are currently available for 50,000 coronavirus patients, and the company expects to have 300,000 doses within the next several months.

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The experimental treatment is still in large-scale clinical trials but has been available for compassionate use, something the FDA approves on a case-by-case basis, such as the case with the president.

REGN-COV2 is a combination of two monoclonal antibodies designed specially to block SARS-CoV-2, the virus that causes COVID-19. Regeneron scientists sorted through thousands of human antibodies, including from people who recovered from COVID-19, to choose ones that fought the virus most effectively.

Scientists chose two virus-neutralizing antibodies, scaled them up and put them into a medication in hopes that it could treat virus symptoms and possibly be used as a preventative measure.

The president received an 8 gram dose of the treatment on Friday at Walter Reed National Military Medical Center following his coronavirus diagnosis. Trump called the treatment “unbelievable” and said he “felt good immediately.”

Early data from the company’s clinical trials have shown that the treatment is effective and safe, with few side effects.

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