Ben Carson says he was ‘desperately ill’ with COVID-19

22 Novembre, 2020, 14:38 | Auteur: Yves Courtet
  • COVID-19 crisis US FDA issues emergency use approval for Regeneron antibody given to Trump

Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy.

The US Food and Drug Administration will allow for the emergency use of Regeneron's Covid-19 antibody treatment. REGN-COV2 was one of the treatments President Donald Trump received after he was admitted to the hospital with Covid-19.

The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35. Early studies showed the therapy was effective in keeping the Covid-19 infection in check and reducing medical visits in patients who get the drug early in the course of their disease, FDA said.

"Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021", the company said in a news release Saturday. "Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system".

Patients treated with the drug also had lower levels of virus remaining compared to those on the placebo.

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Initial supplies will likely be vastly outstripped by demand as the US has surged past 10 million reported cases, with the country facing what health experts say will be a dark winter due uncontrolled spread of the virus.

Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs.

There are several monoclonal antibody treatments that are in the experimental phase of testing and have not been given an emergency use authorization by the FDA. The report noted that more than 360,000 cases have been added in the last two days only.

The emergency authorisation for Regeneron's drug is, however, limited in scope.

Meanwhile, it is likely that Pfizer and Moderna, two pharmaceutical giants, will start distributing COVID-19 vaccines in the United States soon after they have reported more than 90 per cent efficacy in human clinical trials.

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