The treatment has to be infused into the bloodstream and is meant to mimic an immune response to infection.
Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need".
REGENERON'S antibody drug given to outgoing U.S. president Donald Trump after he was diagnosed with Covid-19 has been approved in the US. In issuing an EUA, the FDA evaluates the available scientific evidence and balances the potential risks with benefits of the product.
The treatment combines two antibodies - casirivimab and imdevimab - and administers them together by IV.More news: Borussia Dortmund forward Erling Haaland wins Golden Boy award
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 agency said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. The drug should be given as soon as possible after a positive viral test, according to the FDA. The powerful cocktail is for those patients who are at high risk for progressing to severe conditions associated with the virus.
Patients treated with the drug also had lower levels of virus remaining compared to those on the placebo.
At the time of his diagnosis, Carson's office said he was in good spirits, but in a new Facebook post the 69-year-old HUD secretary said he was "extremely sick" before he took the herbal remedy Oleander 4X and saw his condition improve.
Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness.More news: PSG 'completely stopped playing' against Monaco but have Neymar back for Leipzig
"REGEN-COV2 is created to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus", said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. With two antibodies, the hope is to trap and shut down viral replication.
"The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic", said Dr. Patrizia Cavazzoni, acting director of the FDA's Center for Drug Evaluation and Research.
Regeneron isn't the only company that's been working on antibody therapies for the coronavirus.
The treatment is by US biotech company Regeneron Pharmaceuticals Inc. and uses casirivimab and imdevimab to be administered together.More news: Wilson Guides Seahawks Past Cardinals on TNF