Huge COVID study finds remdesivir doesn’t work—FDA grants approval anyway

Enlarge / A vial of Remdesivir during a press conference about the start of a study with severely COVID-19 patients in Hamburg, Germany on April 8, 2020. (credit: Getty | Ulrich Perrey)

The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19-just days after a massive global study concluded that the drug provides no benefit.

The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," FDA Commissioner Stephen Hahn said in a statement. 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."

Early results

The FDA made its decision based on three clinical trials on remdesivir, a repurposed experimental antiviral drug brand-named Veklury. One was a randomized, double-blind, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases. It included 1,062 hospitalized COVID-19 patients, 541 of which received remdesivir. The trial concluded that remdesivir shortened the median recovery time from the infection from 15 days to 10 days. The researchers running the trial defined recovery" of a patient as either a patient being discharged from the hospital-regardless if the patient still had lingering symptoms that limited activities or required supplemental oxygen to be taken at home-or a patient remaining in the hospital but no longer requiring medical care, such as if they were kept in the hospital for infection-control reasons.

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