After dribs and drabs surfacing about Gilead Sciences' COVID-19 hopeful, remdesivir, the first data from a placebo-controlled study are here—at least, an early look at them. Remdesivir cut recovery time for hospitalized COVID-19 patients by four days, or 31%, in a National Institutes of Health-sponsored study pitting the drug against placebo in more than 1,000 patients.
Based on the results, the FDA could greenlight remdesivir for emergency use as early as Wednesday, a senior administration official said, according to The New York Times.
“Although a 31% improvement does not seem like a knockout 100%, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), said during a White House briefing with reporters Wednesday.
The study, carried out at 68 sites around the world, defined “recovery” as being healthy enough to leave the hospital or return to normal activity level. The trial wasn’t reserved for the sickest of patients—unlike other trials that only included patients with “severe” disease—but the patients still had to be hospitalized with confirmed COVID-19 infection along with “evidence of lung involvement,” like the need for supplemental oxygen or mechanical ventilation. The study did not include patients with milder, coldlike symptoms or those who were asymptomatic.
The results also “suggested a survival benefit,” with a death rate of 8% in patients who received remdesivir and 11% in those who got placebo, NIAID said in a statement. The numbers were too close to be statistically significant, Fauci said, but the data need to be further analyzed and undergo peer review. Gilead is also testing remdesivir in moderately ill patients.
Multiple analysts, meanwhile, used the same metaphor Wednesday to describe the limitations of remdesivir.
“The bottom line is the drug improves patients and clearly appears to help,” wrote Jefferies analyst Michael Yee in an investor note. “It’s not a magic silver bullet but it does improve patients and likely will get broader uptake.”
Evercore ISI analyst Umer Raffat considered the data alongside results from other studies, including a Gilead-sponsored trial testing a five-day course and a 10-day course of remdesivir—with no control arm—as well as a study conducted in China.
“Totality of data… suggests remdesivir ‘works’, but it’s not a silver bullet,” Raffat wrote.
But Fauci doesn’t see remdesivir, an experimental antiviral initially developed for Ebola, as a silver bullet. Rather, he sees it as a steppingstone to better treatments that could even be combined for a greater effect.
“It’s really opening the door to the fact that we now have the capability of treating,” he said. He likened the efforts against COVID-19 to the quest for an HIV treatment decades ago.
“We did the first randomized, placebo-controlled trial with AZT, which turned out to give an effect that was modest. But that was not the end game because building on that every year after, we did better and better. We had better drugs of the same type and we had drugs against different targets.”
President Donald Trump said Wednesday evening, on the heels of the data being revealed, that he wants the FDA to move “as quickly as they can” to approve remdesivir in COVID-19.
“We would like to see very quick approvals, especially with things that work,” he said at a roundtable at the White House. The FDA said it has been talking with Gilead to make remdesivir available to COVID-19 patients “as quickly as possible, as appropriate.” Just last week, and before these latest data were posted, the Japanese government said it was moving to approve the drug under a speedy review process in May.