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FDA Approves Remdesivir for Treatment of COVID-19

On Thursday, the U.S. Food and Drug Administration (FDA) approved the drug remdesivir (brand name Veklury) for patients with COVID-19 over age 12.

In a press release announcing the approval, the FDA said it made its decision based on data from three randomized clinical trials. In one, patients with moderate symptoms given remdesivir for either five or 10 days experienced more symptom improvement than those receiving standard care.

Those with severe COVID-19 symptoms in a second trial were given either a five- or 10-day course of remdesivir. There were no significant differences in symptom improvement or mortality between either course of treatment.

A third clinical trial, the results of which were published in the New England Journal of Medicine earlier in October, showed modest improvement among patients taking remdesivir. The randomized double-blind controlled trial compared remdesivir at two dose levels against a placebo.

The study found that patients given remdesivir had a median recovery time of 10 days, five days shorter than those with the placebo. Researchers also found those who took remdesivir had “lower respiratory tract infection.” The mortality rate for those given the drug were about 4 percentage points lower than the placebo at day 15 and day 29. Nearly 25% of participants given remdesivir experienced a serious adverse event compared to 31.6% of those given a placebo.

Among the three trials presented by the FDA, remdesivir’s effectiveness was determined to be “statistically significantly higher.” It’s important to note, however, that statistical significance is very different than clinical significance, or how a medication performs in the real world. Other studies suggest mixed results for remdesivir. A World Health Organization study conducted worldwide, for example, showed the drug had little benefit, according to CNN.

Regardless, the FDA hailed remdesivir’s approval as the first step to find a treatment for a virus that has infected more than 40 million people worldwide.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release. He added:

Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.

Remdesivir is manufactured by Gilead Sciences. It was given fast track and priority review designation by the FDA. The drug can only be administered in hospital or health care settings comparable to inpatient care. An earlier analysis suggested remdesivir may cost between $4,580 to $5,080 per treatment course. Side effects of the medication may include potential liver injury, allergic reactions, rash, nausea, sweating and shivering, among others.

Header image via digicomphoto/Getty Images