Gilead Sciences’ remdesivir has been a crucial treatment for COVID-19 for months, but new data from a “gold standard” trial give a clearer picture of the med’s benefit. The drug, tested against placebo, improved recovery times, reduced chances of patients progressing to more severe stages of illness and significantly cut the risk of death in a subset of patients.
In a U.S. government-led, placebo-controlled, double-blinded study, patients on the drug recovered five days faster than those on placebo on average. Severe patients, who made up 86% of the trial, recovered seven days faster on average. The results show that the drug provides a major benefits to patients, their families and healthcare systems, Gilead CEO Daniel O’Day wrote in an open letter.
While investigators initially didn't see a statistically significant death-risk reduction in the overall study group, a post hoc analysis found one group in which the benefit was clear. For patients who received low-flow oxygen, investigators recorded 70% fewer deaths for remdesivir patients compared with those on placebo. That group of patients made up 40% of the overall study.
Aside from those benefits, remdesivir helped prevent patients from progressing to more severe stages of illness. In the remdesivir group, 43% fewer patients went on to require mechanical ventilation compared with those on placebo.
But while remdesivir is "indeed helpful in shortening the duration of disease, reducing the progression to more complicated disease, and probably (but not definitively), saving lives," the "fine print … is perhaps less encouraging than the top line," SVB Leerink analyst Geoffrey Porges wrote in a note to clients.
The drug didn't conclusively improve survival at Day 29, "which is the endpoint of most importance in the end," he noted.
Plus, benefits from the treatment were "almost entirely in one group of patients," Porges wrote. For those who were hospitalized and requiring oxygen—but not ventilation or high-flow oxygen—there were "significant" benefits. But for the sickest patients, "remdesivir produced no benefit," Porges wrote.
"Remdesivir ain’t a miracle drug, but it’s the best we got right now," he said.
For their study, investigators tested remdesivir against placebo in about 1,060 patients hospitalized with COVID-19 worldwide. The team unveiled preliminary results from the trial in late April, and the FDA issued an emergency use authorization (EUA) days later.
Even before Gilead secured its EUA, the company had been working to build its remdesivir supply and manufacturing capacity. Now, the drugmaker says it’s able to meet demand for all hospitalized patients in the U.S., O’Day wrote. The company expects to be able to meet global demand later this month.
Just this week, the company entered a procurement deal with the European Commission. The deal allows member countries to buy the drug for both real-time demand and stockpiling needs, with those purchases coordinated by the European Commission.
While the U.S. government originally handled distribution of remdesivir in the U.S., Gilead Sciences has taken the responsibility back.