By Deena Beasley
(Reuters) – The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.
Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with COVID-19.
The FDA’s formal approval comes just hours before the president’s final debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential election.
Remdesivir has been available under an FDA emergency use authorization (EUA) since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days.
However, the World Health Organization (WHO) last week said its global trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been reviewed by outside experts.
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.
Remdesivir, which will be sold under the brand name Veklury, costs $3,120 for a five-day treatment course, or $2,340 for government purchasers such as the Department of Veterans Affairs. Shares of Gilead rose 4.3% in after hours trading to $63.30.
Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival. The drug also has not been proven to significantly help moderately-ill patients, and many doctors remain wary of using it in patients with less severe illness.
“The formal FDA approval doesn’t change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval,” Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines and approval “pretty much a best case for Gilead,” given the WHO results questioning remdesivir’s benefits.
Gilead said it is currently meeting demand for the drug in the United States and anticipates meeting global demand by the end of October.
The company said Veklury has regulatory approvals or temporary authorizations in about 50 additional countries.
Also on Thursday, the FDA issued a new emergency use authorization for remdesivir to treat hospitalized pediatric patients under age 12 who weigh enough to receive an intravenous drug.
Gilead said it is still working to understand the full potential of remdesivir, in different settings and as part of combination therapy approaches. The company is also developing an inhaled version of the drug that might be used outside a hospital setting, if approved.
(Reporting by Vishwadha Chander in Bengaluru and Deena Beasley in Los Angeles; Editing by Cynthia Osterman and Bill Berkrot)
The World Health Organization on Friday addressed criticism from drugmaker Gilead over the group’s interim finding that the antiviral remdesivir has “little or no effect in preventing death from COVID-19 or reducing time in hospital.”
WHO’s interim trial results, which it said would be published soon in a peer-reviewed journal, sparked pushback from Gilead, which said in a statement that the data appears inconsistent with evidence from other studies of the drug.
“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,” the company said in a statement.
Remdesivir, which was given to President Donald Trump when he contracted COVID-19, has been administered to thousands of patients in the U.S. following its emergency use authorization from the Food and Drug Administration.
Photos: Daily Life, Disrupted
Gilead contends that because the trial prioritized broad access, which resulted in “significant heterogeneity in trial adoption, implementation, controls and patient populations,” it is unclear if the study’s findings are conclusive.
But WHO Director General Tedros Adhanom Ghebreyesus defended the so-called Solidarity Trial, which was launched to study the effectiveness of remdesivir and three other drugs in treating COVID-19, as the largest trial in the world. It included more than 11,000 coronavirus patients across 30 countries, with more than 2,700 participants given remdesivir.
“For the moment, the corticosteroid dexamethasone is still the only therapeutic shown to be effective against COVID-19, for patients with severe disease,” Tedros said at a press conference.
The organization reported “factually on what we found,” WHO’s Chief Scientist Soumya Swaminathan said, adding that “we believe that the results are very robust.”
WHO’s guideline development group will examine the data and possibly update their policy on the use of remdesivir in a couple weeks.