U.S. FDA Grants Emergency Use Authorization to Regeneron COVID-19 Antibody Given to Trump

The company said it expects to have does of REGEN-COV2 treatment ready for about 80,000 patients by the end of this month, about 200,000 patients by the first week of January

Reuters
Reuters
Send in e-mailSend in e-mail
President Donald Trump pulls off his protective face mask as he poses atop the Truman Balcony of the White House after returning from being hospitalized at Walter Reed Medical Center, October 5, 2020.
President Donald Trump pulls off his protective face mask as he poses atop the Truman Balcony of the White House after returning from being hospitalized at Walter Reed Medical Center, October 5, 2020.Credit: Erin Scott/ REUTERS
Reuters
Reuters

The U.S. Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc's COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.

The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

This includes those who are 65 years of age or older or who have certain chronic medical conditions.

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.

Regeneron's REGEN-COV2 "antibody cocktail" - containing an antibody made by the company and a second isolated from humans who recovered from COVID-19 - is designed so that the two antibodies seek out and bind to the coronavirus' spike protein to prevent it from entering healthy human cells.

Regeneron said on Saturday the clinical evidence from outpatient trial suggests 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.

The company said it expects to have does of REGEN-COV2 treatment ready for about 80,000 patients by the end of this month, about 200,000 patients by the first week of January and approximately 300,000 patients in total by the end of January.

The FDA said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Click the alert icon to follow topics:

Comments

SUBSCRIBERS JOIN THE CONVERSATION FASTER

Automatic approval of subscriber comments.

Subscribe today and save 40%

SUBSCRIBE
Already signed up? LOG IN

ICYMI

Trump and Netanyahu at the White House in Washington, in 2020.

Three Years Later, Israelis Find Out What Trump Really Thought of Netanyahu

German soldier.

The Rival Jewish Spies Who Almost Changed the Course of WWII

Rio. Not all Jewish men wear black hats.

What Does a Jew Look Like? The Brits Don't Seem to Know

Galon. “I’m coming to accomplish a specific mission: to increase Meretz’s strength and ensure that the party will not tread water around the electoral threshold. If Meretz will be large enough, it will be the basis for a Jewish-Arab partnership.” Daniel Tchetchik

'I Have No Illusions About Ending the Occupation, but the Government Needs the Left'

Soldiers using warfare devices made by the Israeli defense electronics company Elbit Systems.

Russia-Ukraine War Catapults Israeli Arms Industry to Global Stage

Flame and smoke rise during an Israeli air strike, amid Israel-Gaza fighting, in Gaza City August 6, 2022.

Israel Should End Gaza Operation Now, if It Can