Gilead Sciences’ antiviral remdesivir got an emergency authorization from the FDA to treat COVID-19 in May on the basis of a study showing the drug cut the recovery time for hospitalized patients by 31%. But a new and much larger study has reached a very different conclusion.
The World Health Organization (WHO) released preliminary results from a trial involving 11,266 COVID-19 patients in 30 countries who were treated with one of four drug regimens, including remdesivir. The drug “appeared to have little or no effect on hospitalized COVID-19” patients, as measured by the need for ventilation, the length of hospital stay and overall mortality, according to the study, which was posted (PDF) on the journal preprint site medRxiv.
Gilead lashed out shortly after WHO released the study results Thursday. “We are concerned that the data from this open label global trial have not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design,” Gilead said in a statement (PDF).
The trial admitted a broad selection of patients, resulting in heterogeneity that makes it “unclear if any conclusive findings can be drawn from the study results,” the company added.
The WHO trial, which is ongoing, is designed to rapidly evaluate emerging COVID-19 treatments in large patient populations. The newly released data cover remdesivir as well as hydroxychloroquine, protease inhibitor lopinavir and interferon. All four were determined to be of little use in treating COVID-19.
The trial, called Solidarity, is “adaptive,” meaning it will shift along with changes in COVID-19 care over time. Hydroxychloroquine and lopinavir were dropped as they fell out of favor, according to the WHO study. The organization intends to add emerging COVID-19 treatments, such as monoclonal antibodies, in the future.
Gilead expects remdesivir, which carries the brand name Veklury, to bring in $3.5 billion this year. The company is so optimistic about the drug’s uptake during the COVID-19 pandemic that in July it upped its total revenue expectations for the full year to between $23 billion and $25 billion, up from its previous forecast of $21.8 billion to $22.2 billion. And its expansion plans for the product include testing an inhaled version of it in patients who aren’t hospitalized.
Shortly thereafter, the FDA expanded its authorization for remdesivir to include all hospitalized COVID-19 patients regardless of the severity of their disease. That came after a phase 3 trial showing moderately ill patients on a 5-day course of the drug were 65% more likely to see improvements in their symptoms than were patients who only got the standard of care.
But the study was far from a slam dunk: The improvement was not statistically significant for patients who took remdesivir for 10 days.
More recently, remdesivir got a bit of free advertising from U.S. President Donald Trump, after his personal doctor revealed earlier this month that he had been treated with the Gilead antiviral.
In its study, WHO deemed its overall findings “unpromising” and enough to “refute early hopes” that remdesivir and the other drugs would significantly affect outcomes in COVID-19. The main need going forward, the authors wrote, “is for better treatments.”