BREAKING NEWS: FDA has APPROVED experimental drug Remdesivir for emergency use for coronavirus patients, Donald Trump reveals, days after study showed it may help the worst-hit
President Donald Trump announced Friday that the FDA has approved the experimental drug remdesivir for emergency use in hospitalized coronavirus patients.
'I'm pleased to announce that Gilead now has an E wave from the FDA for remdesivir,' Trump said.
It is the first drug shown to help fight the disease, which has killed more than 64,000 people in the United States.
President Donald Trump announced the FDA has approved the experimental drug remdesivir for emergency use in hospitalized coronavirus patients
Daniel O'Day, CEO of Gillead Sciences Inc, said his company would donate 1.5 million doses of the drug during the announcement with President Trump and Stephen Hahn, commissioner of the Food and Drug Administration
Vice President Mike Pence, Daniel O'Day, CEO of Gillead Sciences Inc., left, Stephen Hahn, commissioner of the U.S. Food and Drug Administration, and Dr. Deborah Birx, White House coronavirus response coordinator, listen as President Donald Trump announces the FDA approval for emergency use of remdesivir
Remdesivir is the first drug shown to help fight the disease, which has killed more than 64,000 people in the United States
Gilead's chief executive officer Daniel O'Day, whose company produces remdesivir joined President Trump, Vice President Pence, Dr. Deborah Birx, Health and Human Services Secretary Alex Azar and FDA Commission Stephen Hahn for the announcement.
O'Day pledged to donate 1.5 million doses of the drug to help patients in need.
'What I would like to say on behalf of Gilead and the president's point, we feel a tremendous responsibility. We are humbled with this first step for hospitalized patients. We want to make sure nothing gets in the way of these patients getting the medicine. So we made a decision to donate 1.5 million vials of remdesivir. We will be working with the government to determine how best to distribute that within the United States,' he said.
'We will be working very closely to get that to patients, working with FEMA and other parts of the government to make sure that we get that to the patients in need as quickly as possible. There are patients out there that can benefit from this medicine today that are hospitalized. We don't want any time to waste for that,' he added.
The company has been pushing for FDA approval of the drug. It was given after preliminary results from a government-sponsored study showed that remdesivir shortened the time to recovery by 31 per cent, or about four days on average, for hospitalized coronavirus patients.
The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after President Trump promoted it.
The antiviral remdesivir has shown promise for treating coronavirus, and the head of the drug's maker, Gilead Sciences, said he's committed to ensuring anyone who needs the drug will have access to it.
'We’re going to work very closely with the government and with health care systems to make sure that it’s accessible, that it’s affordable to governments,' said O'Day in conversation with Stat News.
'We’re going to make sure that access is not an issue with this medicine.'
A list price for remdesivir is not available but a recent study published in the Journal of Virus Eradication found that manufacturing a 10-day treatment course would cost about $9.
Earlier this year, Gilead donated its 1.5 million dose stockpile of remdesivir for research on its use for treating coronavirus including the NIH study that Dr Anthony Fauci said Wednesday suggested that the drug 'can block this virus.'
Remdesivir costs about $1 a day to make, and the CEO of the company that developed it, Gilead, said the firm is committed to ensuring 'access' to the drug
Gilead Sciences CEO Daniel O'Day said his company would make remdesivir affordable amid the pandemic after stocks surged in response to the reveal of 'positive data' on its effects in coronavirus patients
On Thursday, the Gilead said in an earnings report that it could make 140,000 treatment courses by the end of May (although O'Day slightly revised this estimation in conversation with Stat) and 'several million' courses over the course of next year.
'This is a global pandemic,' O'Day said to Stat.
'There should be no question about our ability to get medicine in the hands of patients, and that’s how we’re going to approach the period of time after the donation.'
His company has already begun ramping up production of remdesivir, a drug it originally developed to treat Ebola, although it flopped in trials for that disease.
O'Day said that the company currently has enough remdesivir on hand for more than 50,000 10-day treatment courses.
'Look, I think we understand the responsibility that we have as a company,' O'Day said.
'That’s exactly why, as we thought through the best approach to making this drug available in the early days, we thought it was very important to move with a donation of our entire existing supply.
'First of all, it’s just the right thing to do. And secondly, it was going to facilitate access in recognition of the public health emergency and the fact that data was still developing on the medicine and regulatory processes were still underway.
'We didn’t want access to be encumbered at all in the beginning, which is why we just went for a donation right up front of 1.5 million doses.'
Gilead has not always had a reputation as a philanthropic company.
In 2019, the US government filed a complaint against Gilead over its pricing for Truvada, an HIV treatment and prevention medication.
While the drug's generic costs just $6 a month, Gilead's sets buyers back an average of $2,184 per monthly prescription.
In terms of sheer manufacturing costs, remdesivir was the third most expensive of the eight drugs assessed by the Journal of Virus Eradication, at just under a dollar a day:
- $1.45/day for favipiravir
- $1.09/day for pirfenidone
- $0.93/day for remdesivir
- $0.39/day for sofosbuvir/daclatasvir
- $0.28/day for lopinavir/ritonavir
- $0.10/day for azithromycin
- $0.08/day for hydroxychloroquine
- $0.02/day for chloroquine
Overall, the study found a single treatment course for any of those drugs would cost between 30 cents and $31, although the authors noted that all of them are priced significantly above those costs, especially in the US.
O'Day stressed that his company is not looking to profiteer based on the promising effects of remdesivir for treating coronavirus.
'Let me just say that I’m fully committed and the company is fully committed and the board’s really committed to our responsibility, again, with this pandemic medicine,' O'Day said when pressed on the matter by Stat.
'It’s walking the talk, right?...Let’s make sure that if this medicine is effective, that there are no obstacles, particularly given the urgency and the plight of this pandemic around the world.
'I can assure...the general public, that Gilead will continue to take its responsibility very seriously here and make sure that whatever model we come up with will ensure access around the globe, and that patients are put first, and that we work with governments around the globe to make sure we have a sustainable way of supplying this medicine. But we understand our responsibility in this kind of pandemic.'
'Positive data' from the NIH trial of remdesivir sent the stock market soaring by 530 points on Wednesday.
After Dr Anthony gave details of the NIH study on Wednesday, the New York Times reported that the Food and Drug Administration (FDA) plans to give emergency use authorization for the drug to treat coronavirus patients - potentially that same day (the agency has not yet made a formal announcement to that effect).
Wednesday, the same day that the preliminary data from the NIH trial were revealed, Gilead announced results from the first stage of its clinical trial of remdesivir in severely - but not critically - ill coronavirus patients.
Half of the 397 patients, who were sick enough to need additional oxygen but not to be placed on ventilators, improved within 10 days of a five-day treatment course and those who were on a 10-day regimen were better by the eleventh day.
More than half of the patients were discharged from the hospital within two weeks, Gilead announced in a press release.
The announcement of promising preliminary remdesivir results sent the Dow soaring by more than 500 points, though Gilead's own stocks were halted pre-trading as it prepared to announce results of the trial.
And the mutual benefits seen whether patients treated with a five-day or 10-day course of the drug suggest that the company's production potential could stretch twice as far as the projections announced Thursday.
Most people who contract coronavirus develop relatively mild or moderate illness.
Between March 1 and April 18, 9,483 Americans with confirmed coronavirus were hospitalized and reported to the Centers for Disease Control and Prevention (CDC).
That equates to a rate of about 1,355 people who become sick enough to need medical care and potentially oxygen support (though not necessarily mechanical ventilation).
If those rates remained stable, Gilead could handily make enough doses of remdesivir to treat every newly-hospitalized coronavirus patient with a 10-day treatment course well past May. In fact, 140,00 treatment courses would be enough to treat all newly-hospitalized patients in the US for 103 weeks.
However, the CDC's figures are likely a significant undercount, considering that in New York, nearly a thousand people have been newly-hospitalized for coronavirus each of the past three days (and more in prior weeks and days).
Cases of coronavirus in the US surge past one million and deaths have eclipsed President Trump's 'best case scenario' of 60,000 fatalities in the country.
To-date, there are no proven treatments for coronavirus, but the remdesivir results hint that there could be soon.
Outcomes for the members of the NIH's trial of more than 1,090 people who were treated with remdesivir were better by a wide enough margin that Dr Fauci insinuated those who had been given a placebo should now get the drug.
'You have an obligation to immediately let the people in the placebo group know so they can have access [to the potential treatment],' Fauci said in a White House meeting.
Remdesivir is an antiviral medication that Gilead originally developed to treat Ebola, but it faltered in trials.
First petri dish and animal studies showed that it might bat back the coronavirus, and smaller studies were promising enough to prompt the NIH to launch a large, 'gold standard' trial of the drug.
During a White House meeting, Dr Anthony Fauci revealed details of the study, and said he was 'optimistic' about its potential benefits for coronavirus patients
'The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive,' O'Day wrote.
'They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo.'
Alluding to his company's prior attempts to use the drug to treat Ebola, he added: 'After years of research and hard work on remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile.'
In the White House meeting, Dr Fauci explained that remdesivir appears to block an enzyme that coronavirus relies on to attack human cells and hijack their machinery to make more copies of itself.
'We have a drug that can block the virus,' he said.
'This will be the standard of care.'
One of the doctors who administered the drug to patients in the NIH trial echoed both Dr Fauci's and O'Day's optimism on Good Morning America.
Dr Aneesh Mehta, who helped run the NIH trial, called remdesivir a 'glimmer of hope'
'Having taken care of patients for eight weeks now... we've been getting patients better but we're now looking to find a medication that gets them better and faster and home to their families,' said Dr Aneesh Mehta of Emory University, one of the institutions that took part in the study.
'Now, we have the first glimmer of hope of something that can do that.'
Dr Mehta added that the data from the NIH study is still preliminary, and Dr Fauci admitted that the early results were not a 'knock out,' despite his sunny presentation of them.
A remdesivir study of 237 coronavirus patients done in China, also published yesterday, returned disappointing results.
People given the drug did not recover any more quickly and were not at a lesser risk of death, compared to those who got a placebo.
The trial was stopped short of its planned end-date because the researchers were struggling to recruit participants.
Remdesivir appears to work better when given early - as suggested by the NIH trial as well as the SIMPLE trial that Gilead is running - so one theory is that the Chinese patients got the drug too early.
Encouraging though the results of these early trials are, experts around the world caution that the studies need to be done and interpreted thoroughly and carefully.
It comes after studies showed that remdesivir, made by California-based Gilead Sciences, helped patients go from relying on oxygen to leave hospital in two weeks.
Fauci added that the trial was proof 'that a drug can block this virus,' and compared the finding to the arrival of the first antiretrovirals that worked against HIV in the 1980s, albeit with modest success at first.
This would make remdesivir the third drug approved under the EUA by the FDA after the agency approved anti-malaria drugs chloroquine and hydroxychloroquine. The drug is often used to treat Ebola patients.
A separate trial from California-based Gilead Sciences showed the drug helped patients go from relying on oxygen to leaving hospital in two weeks. Pictured: A five-day view of Gilead stock shows the shares rising sharply at the open on Wednesday
Remdesivir has been among the top contenders of existing drugs being trialed for treating coronavirus, although World Health Organization documents leaked last week suggested it had failed to help patients in a more than 200-person trial recover.
Gilead defended the trial, saying it believed the leaked data was a 'mischaracterization' of the results.
On Wednesday, Gilead said the study had produced 'positive data' for treating coronavirus patients.
Half of the 397 patients, who were sick enough to need additional oxygen but not to be placed on ventilators, improved within 10 days of a five-day treatment course and those who were on a 10-day regimen were better by the eleventh day.
More than half of the patients were discharged from the hospital within two weeks, Gilead announced in a press release.
The announcement of promising preliminary remdesivir results sent the Dow soaring by more than 500 points, though Gilead's own stocks were halted pre-trading as it prepared to announce results of the trial.
The NIH is also studying remdesivir in a randomized controlled trial of 400 patients, meaning about half of the group would take the Ebola antiviral, and the others would get a placebo drug.
Gilead's trial did not have a placebo arm, which makes it impossible to know whether the drug helped patients or they improved on their own.
In a statement, Gilead Sciences said it was 'aware of positive data emerging from' the from the National Institute for Allergy and Infectious Diseases, which Dr Fauci runs.
'We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing,' the statement read.
The NIAID said that patients on the drug had a 31 percent faster time to recovery than those on a placebo.
Fauci said although the results weren't a 'knock out 100 percent,' it was an important proof of concept.
'The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,' he told reporters at the White House.
'This is very optimistic, the mortality rate trended towards being better in the sense of less deaths in the REM designate group. Eight percent versus eleven percent in the placebo group.
'So bottom line. You're going to hear more details about this this will be submitted to a peer reviewed journal, and will be peer reviewed appropriately.'
He added that the trial was proof 'that a drug can block this virus,' and compared the finding to the arrival of the first antiretrovirals that worked against HIV in the 1980s, albeit with modest success at first.
For the phase 3 trial announced Wednesday, Gilead treated 397 severely ill patients with its antiviral drug.
The company's Wednesday press release did not specify the locations of the patients. However, it announced in March the initiation of two trials of the drug, one of which would study 400 patients in the Hubei Province of China, where coronavirus first emerged.
The ages and sexes of those patients were not disclosed.
The company tried two different treatment regimens for severely ill coronavirus patients - a five-day and 10-day course - but did not include a control arm of patients who did not receive the drug.
COVID-19 is considered 'severe' if a patient is hospitalized and needs supplemental oxygen.
Among those who were treated for five days, 60 percent could go home by day 14.
In the 10-day treatment group, 52 percent were discharged within two weeks.
Full recovery was achieved on the same timeline by 53.8 percent of the 10-day treatment group, and by 64.5 percent of people in the five-day treatment group.
'These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,' said Dr Aruna Subramanian, a Stanford University infectious diseases professor who helped lead the study.
Gilead is expanding upon the study by testing the drug in a further 5,600 patients at 180 locations for the next stage of its SIMPLE trial.
It will be trialed around the world, including in the US, the UK, China, France, Germany, Hong Kong, Italy, Japan Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland, and Taiwan.
These trials will include patients who need mechanical ventilation to survive as well, and will compare the two treatment regimens (five- and 10-day courses) to those given the standard of supportive care.
Gilead said it expects to report results on the first 600 patients involVed by the end of May.
'While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective.'
That's not to say that there weren't patients who fared poorly.
Seven percent of coronavirus patients treated outside Italy died. It's not clear how many patients were treated within Italy versus outside of the hard-hit nation.
Timing mattered as well.
People who were treated early - within 10 days of their first symptoms - fared better, with 62 percent being discharged from the hospital within 14 days.
Severely ill coronavirus patients, like those treated in the remdesivir trial, require oxygen to keep them alive, including mechanical ventilation (pictured). Safe treatments for these people are badly needed, as an estimated 80% of those put on ventilators will not survive (file)
Gilead Sciences was dealt a blow last week when leaked data suggested that remdesivir was not helping coronavirus patients, but this week's trial results suggest otherwise
A table from Gilead shows that more than half of the patients in each treatment group recovered and were discharged from the hospital, although a total of 37 patients died
But the trial's results suggest the drug may still be beneficial, even if given relatively late. Nearly half of those who received remdesivir 10 or more days after they developed symptoms were also released from the hospital by day 14.
Generally speaking, the drug appeared safe in the trial, regardless of the duration of the treatment course.
More than 10 percent of patients treated with the antiviral became nauseous, and six percent of the five-day treatment group and 10.7 percent of the 10-day treatment group were in acute respiratory failure (also a complication of the infection itself).
The greatest risk posed to the coronavirus patients treated with remdesivir was liver damage.
Lab work showed enzyme build up in 7.3 percent of the patients. the risk of liver damage became great enough that three percent were removed from the trial.
Dow jumps 550 points after Gilead reported 'positive data' for its experimental coronavirus treatment
BREAKING NEWS: FDA has APPROVED experimental drug Remdesivir for emergency use for coronavirus patients, Donald Trump reveals, days after study showed it may help the worst-hit
![BREAKING NEWS: FDA has APPROVED experimental drug Remdesivir for emergency use for coronavirus patients, Donald Trump reveals, days after study showed it may help the worst-hit]()
Reviewed by Your Destination
on
May 02, 2020
Rating:
No comments