The U.S. Food and Drug Administration on Thursday approved Gilead Sciences’s antiviral drug remdesivir for the treatment of adults with COVID-19, making it the first and only FDA-approved treatment for the disease in the United States.
Gilead Sciences has branded its version of remdesivir as “Veklury.” It is administered intravenously to hospitalized patients.
The FDA also on Thursday issued a new emergency use authorization (EUA) for remdesivir to treat hospitalized pediatric patients under age 12 who weigh at least 3.5 kg—enough to receive an intravenous drug.
The FDA said on Thursday that it gave Veklury approval after analyzing data from three randomized, controlled clinical trials of patients hospitalized with mild-to-severe COVID-19. One of the three studies was the NIAID-sponsored ACTT-1 trial, while the other two studies were sponsored by Gilead.
Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of which treatments were being used. The company told the Financial Times on Oct. 15, “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of remdesivir. We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”
Merdad Parsey, Chief Medical Officer of Gilead, said that remdesivir is “the first antiviral treatment proven to help patients hospitalized with COVID-19 recover more quickly.”
Parsey said that the WHO’s study “provided information about Veklury in real-world settings in the early days of the pandemic,” but “does not negate other study results—particularly from a trial designed with the strictest of scientific standards, as is the case with ACTT-1.”
Gilead is charging government health programs in the United States and other developed countries $2,340 for a typical five-day treatment course, and private insurance companies $3,120 for the same treatment. The amount that patients pay out of pocket depends on insurance, income, and other factors.
President Donald Trump was treated with remdesivir earlier this month when he contracted COVID-19. He also had other treatments, including an experimental antibody cocktail treatment from Regeneron Pharmaceuticals Inc., which he credited for his recovery. Trump was also on other medications and supplements at the time, including “zinc, vitamin D, famotidine, melatonin, and a daily aspirin,” according to his physician.
