Regeneron Gets Emergency US Clearance for COVID-19 Therapy

Pedestrians walk past a store with guidelines for social distance and face masks

"This FDA Emergency Use Authorisation is 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", said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.

"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system", said Stephen Hahn, commissioner of the Food and Drug Administration (FDA).

The Regeneron treatment is a combination of two monoclonal antibodies - potent, laboratory-made antibodies - which mimic our own immune response.

The FDA said in clinical trials Regeneron's treatment reduced COVID-19-related hospitalizations or emergency room visits in high risk patients. REGN-COV2 was one of the treatments President Donald Trump received after he was admitted to the hospital with Covid-19.

They work by binding to a surface protein of the SARS-CoV-2 virus and stopping it from invading human cells. The FDA's review determined that it is reasonable to believe that casirivimab and imdevimab administered together may be effective in treating patients with mild or moderate COVID-19.

Chart showing cases and deaths in the US. Updated 21 Nov
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Advertisement. Scroll to continue reading. It is to note that the treatment has received an emergency approval for patients who have not been hospitalized yet but are at a high risk.

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. "We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination". The report noted that more than 360,000 cases have been added in the last two days only.

The drug, developed by Regeneron, will be allowed for use in people who have tested positive for the virus and are at risk of severe illness.

Regeneron has received more than $450 million from the USA government for its Covid-19 drug development efforts under Operation Warp Speed. Monoclonal antibodies, such as casirivimab and imdevimab, could lead to worse outcomes for hospitalized patients requiring high flow oxygen or mechanical ventilation, the FDA said.

"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.


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