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.
“Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” the FDA announced, noting that the drug is being formally approved—beyond an emergency use authorization—for use in patients aged 12 and older, weighing at least 40 kilograms (about 88 pounds).
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.
Velukry has been available under an FDA EUA since May, after a study (ACTT-1 trial) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) showed it reduced hospital stays by five days from an average of 15 days.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement. “As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
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.
The World Health Organization (WHO) last week said on Oct. 15 that its COVID-19 therapeutics trial of multiple treatments for COVID-19 found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been peer reviewed.
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.”
“In less than one year, the world has moved from a sense of desperation to understand an unknown disease spreading all too quickly and taking lives, to one of hope that we now have enough knowledge and a growing set of tools to help fight COVID-19,” he said in a statement. “With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury (remdesivir) is one of the tools available today.”
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.
So far, only steroids such as dexamethasone have been shown to lower the risk of dying of COVID-19. The FDA also has granted EUAs to using the blood of survivors (convalescent plasma), and two companies are currently seeking similar emergency authorization for experimental antibody drugs.
Isabel van Brugen, Reuters, and The Associated Press contributed to this report.