FDA approves new COVID drug for mild cases under emergency use authorization

BISMARCK, N.D. (KFYR) - There’s a new drug approved for treatment of COVID-19. And, you might have heard about it before.

Regeneron Pharmaceuticals Incorporated recently got the “okay” from the Food and Drug Administration for its “COVID cocktail” that President Donald Trump was prescribed about a month ago.

The FDA cleared Regeneron’s antibody treatment on Saturday for emergency use in COVID-positive patients with mild to moderate symptoms. The company’s CEO reported Monday, Regeneron will provide the U.S. with 300,000 doses of the drug.

The FDA reports the use of Regeneron’s new treatment may be effective in treating patients with COVID-19. After a clinical trial, researchers concluded the drug is shown to reduce COVID-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment.

“We have shown that it works best in the patients who have not yet made their own immune response against the virus,” said Regeneron Co-founder, President, Chief Scientific Officer Dr. George Yancopoulos.

Trump took the drug in October to treat his case of COVID-19.

“They gave me something, Regeneron, and a day later, I felt like Superman,” said Trump.

At the time, the drug had not been approved by the FDA. But, patients like Nicole Martinez who was one of the first people to enroll in the drug’s clinical study, say they think the drug could have saved their lives. “Yes, I would have to say that 1,000 percent,” said Martinez, Regeneron clinical trial participant.

However, even now the drug can be administered only under a EUA, which differs from traditional FDA approval. Experts say an EAU means the drug company has gone through most of the steps for approval.

“The FDA reviews the data, they see this drug is looking to be a highly effective and potentially low side effect. But, what they’re really looking at is: currently we have no other option. This is something that could benefit patients,” said CHI St. Alexius Pharmacy Quality and Clinical Research Manager Joan Galbraith.

The safety and effectiveness of the drug for use in the treatment of COVID-19 continues to be evaluated, according to the FDA.

I reached out to Sanford Health, CHI St. Alexius and the North Dakota Department of Health to get more information on what the drug does. However, they say because the drug is so new, doctors there can not explain how it works or how safe it is. We will keep you updated as more information becomes available.

Copyright 2020 KFYR. All rights reserved.