FDA Issues Emergency Approval For Coronavirus Treatment Drug

President Donald Trump and the Food and Drug Administration announced Friday that it has approved the experimental drug remdesivir for treating coronavirus patients who require hospitalization.

The drug is administered intravenously once a day for up to 10 days and is believed to help patients recover faster.

Its manufacturer, Gilead Sciences, plans to donate 1.1 million vials of the drug and will work with the federal government to distribute it, Gilead CEO Daniel O’Day said at the White House on Friday.

Dr. Anthony Fauci, the nation’s leading official on infectious diseases, had touted an international study of more than 1,000 people earlier this week that supported the drug’s use. An independent data monitoring board that works with the National Institute of Allergy and Infectious Diseases, which Fauci leads, determined that the drug was effective.

“The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” Fauci said from the White House on Wednesday.

The randomized, controlled study supporting remdesivir’s effects was released the same day. Beginning in late February, 1,063 patients with advanced COVID-19 in 22 countries were given either the drug or a placebo. The placebo patients recovered after 15 days on average, while the group given the new drug recovered in 11 days on average ― a 31% difference.

The mortality rate for the group given remdesivir was also lower than for the placebo group.

The study still requires peer review, and its data differs from certain other studies that produced disappointing results with remdesivir, meaning that the drug might not be so helpful after all.

But some researchers are optimistic.

“This is really quite important for a number of reasons,” Fauci said. “Although a 31% improvement doesn’t seem like a knockout, 100%, it is a very important proof of concept. What it has proven is that a drug can beat this virus.”

Fauci drew on the medical community’s response to the AIDS crisis to make his point. While the first HIV treatment drug AZT showed “modest” effects in its first clinical trials, subsequent research and testing created a much more powerful drug, he said.

O’Day echoed Fauci’s comparison to the AIDS crisis on Friday, saying although “we’re still early days on the coronavirus, this is the first step today.”

Remdesivir’s manufacturing time has been cut down from 12 months to six months, O’Day said. According to Fauci, it works by “blocking an enzyme that the virus uses.”

In an FDA information sheet for patients and their families, the agency noted that the drug has not undergone a full FDA review. Rather, it was issued an emergency use authorization, which is given when there are no alternatives and scientific evidence shows “it is reasonable to believe that this product meets certain criteria for safety,” according to the sheet.

Gilead is just one of many companies rushing to find a cure for the virus that has crashed the global economy and already killed more Americans than the Vietnam War. A number of other drugs are currently in the works.

As part of their testing, researchers will try combining them with remdesivir to see whether they work better together.

FDA Commissioner Stephen Hahn said in a tweet that the agency was working “around the clock” to speed up efforts to find suitable treatment methods.

A potential COVID-19 vaccine is not expected to become available at least until next year.