Regeneron Gets Emergency US Clearance for COVID-19 Therapy

Henrietta Strickland
November 22, 2020

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.

USA health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month.

According to the report, Regeneron is set to have doses ready for 80,000 patients by the end of this month and come January 2021, around 3 lakh patients can be given doses for these.

Leonard Schleifer, Regeneron's president and CEO, added the move was "an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection".

The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

The drug company, which started clinical trials on June 11, said that preliminary results from a trial reveal that its antibody treatment could reduce the severity of the virus in non-hospitalised patients with Covid-19.

The issuance of an emergency-use authorization is different than an FDA approval, the agency said. Patients with other conditions like diabetes, cardiovascular disease or chronic kidney disease also qualify for the drug. The cocktail has not been authorized for use in patients who are hospitalized with Covid-19 or need oxygen therapy because of Covid-19.

But with cases surging across the USA and globally, that means access will not be widespread.

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. With two antibodies, the hope is to trap and shut down viral replication. Regeneron's antibody treatment was given emergency use approval from the FDA after Eli Lilly's similar therapy was approved on November 9.

"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic", Commissioner Stephen Hahn said in the statement.

Other reports by Click Lancashire

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