FDA to authorize emergency use of new coronavirus treatment

The Trump administration is fast-tracking authorization of the drug remdesivir as a treatment for COVID-19.

The Food and Drug Administration (FDA) on Friday announced the drug will receive an “emergency use authorization” after it showed promising results during a clinical trial.

Early results released this week showed the drug had modest success in reducing the time COVID-19 patients were in the hospital.

President Trump addressed the fast-track authorization during an Oval Office meeting with the CEO of Gilead, which developed the antiviral drug.

“It’s really a very promising situation,” Trump said.

Gilead CEO Daniel O’Day said the drug is an “important first step” for hospitalized patients. The company will be donating about 1.5 million vials of the drug, and the federal government will determine how to distribute it.

On Wednesday, the nation’s top infectious disease doctor Anthony Fauci said the trial results show remdesivir is the new standard of care as other treatments are being developed. 

Remdesivir is still being studied, and the authorization is not the same as being approved for use, but it will allow the drug to be administered by prescription while it is still being studied. The emergency authorization means there are no approved alternatives, and the drug is better than no treatment at all.

In a fact sheet, FDA made clear that all of the risks are not yet known about the drug since it has not undergone the same type of review as an FDA-approved or cleared product. 

“There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19,” the agency said.

Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19. Hospitalized patients with advanced COVID-19 who received remdesivir recovered in 11 days, instead of 15 days for patients on a placebo.