FDA grants emergency approval for new coronavirus treatment remdesivir

President Donald Trump announced on Friday that the Food and Drug Administration (FDA) approved the antiviral drug remdesivir as an emergency use treatment for severe COVID-19 cases.

“I’m pleased to announce that Gilead now has an [emergency use authorization] from the FDA for remdesivir,” Trump said Friday, calling it “an important treatment for hospitalized coronavirus patients.”

“It’s really a very promising situation,” the president said. “We’ve been doing work with the teams at the FDA, [National Institutes of Health], and Gilead for spearheading this public-private partnership to make this happen very quickly.”

What we know

Being an emergency use drug, we don’t know as much about remdesivir as other drugs that undergo the normal FDA approval process. The drug had been shelved after failing to be approved as a treatment for hepatitis and Ebola. But tests showed it had seen success against coronaviruses, including SARS and MERS, and the evidence suggests that remdesivir shows promise with treating COVID-19 patients as well.

According to a recent study by the National Institute of Allergy and Infectious Diseases, remdesivir does appear to shorten recovery time. Those treated with the drug typically recovered four days faster than those who didn’t, recovering in 11 days instead of 15.

Similarly, a study by Gilead, the company that is producing remdesivir, found that at least 50 percent of COVID-19 patients who took the drug over a period of five days showed signs of improvement. It should be noted that this particular study didn’t use a control group.

So, the potential is there. As for side effects, according to CNBC, researchers thus far have found them to include nausea, vomiting, and possibly liver damage.

How it happened

Remdesivir’s path to approval was similar to that of chloroquine and hydroxychloroquine, two other drugs to which the FDA recently granted emergency use authorization to treat COVID-19 patients.

Coronavirus task force member Doctor Anthony Fauci highlighted remdesivir’s potential in a media briefing this week. Watch:

This week, the drug was submitted to the FDA for emergency use authorization. “We would like to see very quick approvals, especially with things that work,” President Trump said on Wednesday. And the president got what he asked for — two days later he was announcing success.

Now Gilead is going into production mode, predicting that it will produce 140,000 remdesivir treatments by the end of May, and possibly a million by the end of the year. A treatment is enough of the drug for a 10-day regimen. Gilead CEO Daniel O’Day also promised that about 1.5 million vials of the treatment will be donated, saying, “We want to make sure nothing gets in the way of these patients getting the medicine.”

As remdesivir is put into use, more will be learned about the drug, including just how successful it is against COVID-19. But at the very least, it now gives doctors and patients another source of hope.

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