Gilead’s Covid-19 Drug Is Mediocre. It Will Be a Blockbuster Anyway.

The United States reached a milestone, of sorts, when last week the Food and Drug Administration approved the first treatment for Covid-19.

The drug is called Veklury, although most people know it by its scientific name, remdesivir.

On Wednesday, its manufacturer, Gilead Sciences, said that remdesivir, which has been authorized for emergency use since the spring, had brought in $873 million in revenues so far this year and that it was the company’s second-best-selling drug in the third quarter, behind its H.I.V. drug, Biktarvy.

But the F.D.A.’s decision to grant the drug full approval — which means the company can now begin broadly marketing it to doctors and patients — has puzzled several outside experts, who say that it may not deserve the agency’s stamp of approval because it is, at best, a mediocre treatment for Covid-19, the disease caused by the coronavirus. And they have questioned whether Gilead deserves to pocket potential billions from the drug when the federal government has played a significant role in its development.

“This is a troubling approval,” said Dr. Peter B. Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “This is an extremely weak set of trials to support an approval for an antiviral.”

Remdesivir was seen as one of the brightest hopes in the dark days of March and April, when doctors had few tools to treat a new disease and families rushed to gain access to the drug in a desperate gambit to save their dying relatives.

More than six months later, enthusiasm has fizzled. One large, government-run trial showed that the drug shortens patients’ recovery times, but the two other studies the F.D.A. used to justify its approval — sponsored by Gilead — did not compare the treatments with a placebo, the gold standard for evaluating a drug. No studies have shown that it significantly lowers death rates.

And just days before the F.D.A. granted approval, a large study sponsored by the World Health Organization found that remdesivir provided no benefit to hospitalized patients.

“I think most people think that because a drug is F.D.A. approved, that means it must work,” said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who studies the drug industry. He and other researchers recently found that less than one-third of new drugs approved by the F.D.A. and its European counterpart over the past decade were rated as having a “high therapeutic value” by outside experts.

“I think it’s important to recognize that F.D.A. approval doesn’t guarantee a certain level of benefit — all it says is that there is some benefit,” he said.

On a call with investors on Wednesday, Gilead’s chief executive, Daniel O’Day, said remdesivir had a role to play, along with vaccines and other treatments.

“There’s a lot we don’t know about the pandemic, of course, but I think what we do know is that in order to get us all back to normal, this is going to

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Mexico will not follow FDA in approving Gilead’s COVID-19 drug

MEXICO CITY (Reuters) – Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday.

Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

“We have no mandate from the FDA,” he said. “Cofepris has identified that the evidence does not suggest a usefulness, a sufficient efficacy.”

The FDA approved remdesivir on Thursday, 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 World Health Organization’s (WHO) Solidarity drug trial last week concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19, and a top WHO scientist on Friday recommended the FDA consider all available evidence.

Lopez-Gatell said Gilead had sent a letter to doctors in Mexico refuting the results of the Solidarity trial, and that officials were looking to see if the letter could be cause for sanction, given that remdesivir is not registered with Mexican health authorities.

“It confuses the population and generates a false expectation of the possibility of having a treatment option,” he said.

Gilead did not immediately respond to a request for comment.

(Reporting by Sharay Angulo and Daina Beth Solomon; Editing by Sonya Hepinstall and Tom Hogue)

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Gilead’s remdesivir gets U.S. FDA approval for hospitalized COVID-19 patients

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)

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WHO Addresses Gilead’s Pushback on Remdesivir Trial | Health News

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

TOPSHOT - A passenger in an outfit (R) poses for a picture as a security guard wearing a facemask as a preventive measure against the Covid-19 coronavirus stands nearby on a last century-style boat, featuring a theatrical drama set between the 1920s and 1930s in Wuhan, in Chinas central Hubei province on September 27, 2020. (Photo by Hector RETAMAL / AFP) (Photo by HECTOR RETAMAL/AFP via Getty Images)

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.

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