Experimental coronavirus drug remdesivir to be distributed again after halt a week ago

Experimental coronavirus drug remdesivir to be distributed again after halt a week ago

SAN FRANCISCO – An experimental and unproven coronavirus treatment so popular new requests to use it were halted a week ago due to "overwhelming" demand is once again available to doctors under an expanded access program.

President Donald Trump called the drug, remdesivir, “promising” 10 days ago, though there is no data yet to show whether it is safe and effective at treating COVID-19. It was originally created as a potential treatment for the Ebola and Marburg viruses.

On Saturday, Gilead Sciences CEO Daniel O’Day announced in an open letter that his company was once again making remdesivir available outside of the six ongoing clinical trials investigating whether it is effective as a treatment for COVID-19

Distribution of the drug will be under a government-approved "expanded access" program.

No data from those trials is yet available that would tell doctors whether the drug helps COVID-19 patients.

O’Day said Gilead, based in Foster City, California, hoped to have at least initial data on whether it works “in the coming weeks.”

Tube of blood marked positive for coronavirus

“We are doing this before knowing whether the drug is safe and effective to treat COVID-19 because of the urgency of the situation,” a company spokeswoman said via email.

Remdesivir can only be administered by intravenous infusion over the course of between 30 and 120 minutes. It is not available as a pill or a shot.

Trump touted the drug, which has never been approved for general use, in a news conference on March 19.

At the time it was only being distributed under "compassionate use" rules requiring each application to be reviewed individually. Typically such programs are reserved for a small number of cases.

So many doctors asked for access to the drug that demand overwhelmed the company. On March 22 Gilead halted review of new individual requests for emergency access to remdesivir outside of clinical trials, except for pregnant women and children.

The system could not "support and process the overwhelming number of applications we have seen with COVID-19," O'Day wrote.

To expedite access, the company announced Saturday it had begun transitioning to a system using an "expanded access" program. This allows hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time.

The initial expanded access sites include two in New York, one in New Jersey and one in Louisiana, the company said Saturday, with more expected to be added.

Pregnant women and children will still have to go through the compassionate use program due to the very limited data available on the drug’s use in those populations, the company said. That will allow it to make a thorough assessment of the benefits and risks and collected follow-up safety data.

In addition to these two programs, there are six ongoing clinical trials of remdesivir as a treatment for COVID-19 internationally.

Two began in China in early February, one for patients with severe disease and one for those with mild to moderate disease. The U.S. National Institutes of Health launched a trial in February to test it on people hospitalized with evidence of lung involvement. The National Institute of Health and Medical Research in France, in conjunction with the World Health Organization, is testing the drug.

Gilead also launched two studies of its own this month, one in patients with severe disease and the other in patients with moderate disease.

The company came under fire last week when it asked for, and was granted, orphan drug status for remdesivir. The status is meant for drugs used for rare diseases and gives drugmakers tax breaks, Food and Drug Administration fee waivers and a seven-year window before other companies can begin to sell generic versions.

There was such an outcry against what many called profiteering that Gilead made the rare decision to ask the FDA to rescind the status.

Fact check: Drugmaker Gilead Sciences claimed rights to a possible COVID-19 treatment

Source: https://www.usatoday.com/story/news/2020/03/28/experimental-coronavirus-drug-remdesivir-trump-lauded-again-available/2934583001/

News Related

ORTHER NEWS

Trump’s ‘mission accomplished’ moment is premature and deadly. We have not defeated COVID.

Desperate for crowds and adoration, Trump has put his most fervent supporters at risk of getting a deadly disease. Future historians will be astonished. Read more »

NFLPA president JC Tretter says NFL is putting season, players at risk with its coronavirus approach

NFL Players Association president JC Tretter said Tuesday the NFL is putting the 2020 season at risk with its coronavirus approach, calling on the league to better “prioritize player safety.” “Like many other... Read more »

Brazilian President Jair Bolsonaro says he tested positive for the coronavirus

RIO DE JANEIRO (AP) — Brazil’s President Jair Bolsonaro says he has tested positive for COVID-19 after months of downplaying the virus’ severity. Bolsonaro confirmed the test results while wearing a mask and... Read more »

Venice Film Festival forges ahead amid COVID-19 pandemic with reduced lineup

The show will go on for the Venice Film Festival in September, but with a few modifications due to the COVID-19 pandemic. Organizers said Tuesday that they are pushing forward with plans for... Read more »

Amtrak offers buy-one, get-one promotion on its sleeper trains amid COVID-19 — with a catch

Amtrak wants you to have sweet dreams the next time you travel — so much so that it’s sweetening the deal on its sleeper “roomettes.” The rail service is offering a buy-one-get-one-free discount... Read more »

Florida teen treated with hydroxychloroquine at home before dying of COVID-19, report says

FORT MEYERS, Fla. – The family of a 17-year-old Florida girl who died last month from COVID-19 treated her symptoms at home for nearly a week before taking her to a hospital, a... Read more »

Mookie Betts worried MLB coronavirus testing woes could prevent him from ever playing for Dodgers

During nearly four months away from the game, Mookie Betts said he “stayed away from baseball to keep myself sane.” It’s not hard to understand why. The 2018 American League Most Valuable Player... Read more »

Tom Hanks doesn’t get ‘how common sense has somehow been put into question’ with coronavirus

Read more »

Can Gov. DeSantis force Florida schools to reopen amid the coronavirus pandemic? Some school leaders seem doubtful.

PALM BEACH, Fla. — As concern about the state order spread online, some school leaders said: Not so fast. As Florida educators puzzle over how to start the new academic year, Gov. Ron... Read more »

Texas surpasses 200,000 coronavirus cases after 4th of July holiday weekend

AUSTIN, Texas – Texas reached 200,000 total COVID-19 cases Monday, just 17 days after crossing the 100,000 threshold, a figure that took the state nearly four months to hit. The grim milestone came... Read more »