FDA gives emergency authorization to drug that can keep COVID-19 patients out of the hospital

Elizabeth Weise

Karen Weintraub
 
| USA TODAY

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Companies test antibody drugs to treat COVID-19

With a coronavirus vaccine still many months off, companies are rushing to test what may be the next best thing: antibody drugs that fight the virus right away, without having to train the immune system to do the job. (Aug. 12)

In more good news for the fight against COVID-19, the U.S. Food and Drug Administration late Monday authorized use of a drug that appears to protect infected people at high risk from getting very sick.

The FDA issued an emergency use authorization to drug-maker Lilly for bamlanivimab, a monoclonal antibody that mimics the immune system’s response to infection with the virus that causes COVID-19.

“The data is very solid,” said Dr. Daniel Griffin, head of Infectious Disease at ProHEALTH, an independent, physician-led healthcare organization

The drug is similar to a pair of antibodies made by Regeneron that President Donald Trump has said “cured” him of COVID-19.

Regeneron has also applied for FDA authorization for its drug, REGN-COV2.

FDA’s emergency authorization was based on data from a study of the drug in 465 people who had COVID-19 but weren’t hospitalized. Some patients got the drug, some got a placebo.

Most patients in both groups had cleared the virus from their system within 11 days.

However, in people who were at high risk of severe COVID disease, only 3% of those who got the drug went to the emergency room or were hospitalized. Among people who got the placebo, 10% ended up hospitalized or visiting the ER.

A clinical trial of the same drug in COVID-19 patients who were hospitalized was stopped because the drug didn’t help those patients recover from a more advanced stage of their disease.

“If you’re a hospital administration, you look at the number of hospital bed and ventilators and you think that 3% hospitalization versus 10% hospitalization could make a difference,” said John Scott, a professor in the Department of Pharmacology at the University of Washington School of Medicine in Seattle.

As case numbers rise around the country, “Everything is going to help at the right point in time,” he said. “But it’s not going to help nearly as much as people wearing masks and socially distancing.”

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The federal government has already agreed to spend $375 million to provide 300,000 doses of bamlanivimab for high-risk patients, who will not have to pay out-of-pocket costs for the medication.

According to FDA’s authorization, bamlanivimab is allowed to be used to treat recently diagnosed, mild to moderate COVID-19 in high-risk patients.

Delivered via a single dose infusion, the medication should be given as soon as possible after diagnosis and within 10 days of symptom onset, according to the company. 

FDA did not license the drug but instead granted it an Emergency Use Authorization. This is a fast-tracked approval process that differs from a regular drug license application in several ways, though the company still must prove to FDA the drug is safe and effective. 

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