What the Remdesivir EUA Means for COVID-19 Care, Research

Contagion Editor in Chief Jason Gallagher, PharmD, discusses the new authorization for the controversial antiviral therapy.

On Friday afternoon, the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for antiviral drug remdesivir in the treatment of patients with coronavirus 2019 (COVID-19).

The decision was anticipated since Wednesday morning, when a triplet of differing clinical trial details for the drug were made public. The data, from ongoing trials led by the National Institute of Allergy and Infectious Diseases (NIAID), Gilead Sciences, and a China-based team of investigators published in The Lancet, reported similar benefits for hospitalized patient time to recovery.

But investigators differed on their expressed optimism for the drug—investigators from China reported mixed findings and called for broader, more robust analysis on their part, while NIAID director Anthony Fauci, MD, expressed belief remdesivir could become the new standard of care.

Now that the authorization has come, how should clinicians feel about the drug?

In an interview at the time of pending FDA decision, Contagion Editor in Chief Jason Gallagher, PharmD, clinical professor at Temple University College of Pharmacy, discussed the immediate impact of the remdesivir EUA.

As Gallagher pointed out, the main driver of COVID-19 care thus far has been clinical trial enrollment. With remdesivir becoming largely available, he imagines study participation takes a hit.

“If you’re in a remdesivir clinical trial and you could be randomized to placebo, are you going to enroll now?” he said. “I don’t think so.”

Gallagher also discussed the benefit of a having new data to assess in COVID-19 treatment, as well as the unintended consequences of an FDA authorization for the much-discussed drug after a series of clinical debates.

“Once the horse is out of the barn, we’re going to have to manage everything based upon what people are going to see as a new standard," he said.