Gilead Sciences has temporarily stopped granting patients access to remdesivir, its experimental drug against the novel coronavirus that causes Covid-19, citing “overwhelming demand,” the company said Sunday.
The company said in a statement that it is focused on processing previously approved requests, and that it is developing a new system that it says will allow patients to get the drug in a similar timeframe to what it would have taken to work through the requests it has received.
It will make exceptions for pregnant women and children under 18 years of age with confirmed Covid-19 and “severe manifestations” of the disease.
Remdesivir is being studied in five large clinical trials, two of which could read out results in early April. Up until now, Gilead has made it possible for patients who want the drug to get it through a process called “compassionate use.” To date, the company said, it has provided emergency access to several hundred patients in the United States, Europe, and Japan.
The company said in its statement that “enrollment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine.”
Some severely ill patients, it acknowledges, will be unable to enroll in clinical trials and will not have approved treatment options. For those, it is moving from a “compassionate use” system to expanded access programs. It said the approach will speed up access for severely ill patients and enable the company to collect data from all patients. These programs are under “rapid development” with regulators worldwide.
Gilead said that in recent weeks there has been “an exponential increase” in requests for compassionate use because of the spread of the coronavirus in Europe and the U.S. This has “flooded” its treatment access system, which was set up for very limited access to the medicine and was, it said, “never intended for use in response to a pandemic.”
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Bottom line. This is a crisis/war. Patent law should be voided undee were Marshall law if need be. Gilead should have followed lead other companies to emergency ramp up production. Shame when china doing better job getting possible life saving med to their people ,have better protective gear for their heakthcare workers people and controlling their epidemic better.
Oh as far as liability if my chest xray positive and I’m requiring oxygen supplementation I will gladly sign waiver of liability to get my first bolus. Where do I sign. The 200,000 criteria is arbitrary and capricious in this setting. The rule doesnt define time period of number people infected. This is not a rare disease like scleroderma. Guess follow the money.
FDA made error. Hopefully be reviewed at higher level quickly. This not disease involving less than 200,000. It going be 20 million plus. Gilead able to handle the volume alone and will they be socially responsible? Makes me question our government dedication to ALL its people. Hope Trump and WHO reads this.
Gilead’s Remdesivir updates and information on Orphan Drug Status…
Dr. Ed Hmlin,
With all due respect, what do you know about the FDA’s Orphan Drug designation and review process? Have you read any of these documents?
https://en.wikipedia.org/wiki/Orphan_drug
https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products
https://www.fda.gov/media/109496/download
I certainly have and am familiar with all of them.
So that you know, Gilead never submitted remdesevir for the purpose of Ebola treatment since it did not yield sufficient efficacy data during clinical studies a few years ago. Would be great to read more detail about your comment:
Gilead’s Remdesivir updates and information on Orphan Drug Status…
Jojo,
Please show proof and establish your credibility:
Really Jjjo, how do you and what do you rally know?
You said:
“Actually, Gilead has been ramping production for months. It’s on their webpage. They aren’t waiting for approval, and they had a large stockpile before the pandemic even existed because they were waiting for another after Ebola.”
Unless you are currently a Gilead staff or knows someone at senior management level in manufacturing, pharmaceutical development, regulatory affairs, or clinical research/operations departments, how could you possibly know?
Show your proof or provide supporting info! Where is the webpage? Who are you? Did you ever work at Gilead? Your fake news is abhorrent and disgusting and is a piece of garbage.
John Chu, You need to stop being abusive. The Gilead website says the things he posted. What is your point in being here anyway?
Steve White,
Care to provide the specific link to that information and preferably a cut and paste of the paragraph?
My purpose? Here is what I wrote about myself on a very popular retail investors’ blogsite where I have established myself and also considered by many ( close to 200 followers) as an Gilead expert:
A former Gilead employee dedicated and determined to defend GILD against any and all derogatory, demeaning, and defaming remarks by dysfunctional demagogues and spreaders and creators of fake news about Gilead.
Enough for you?
Why bother trying to synthesize Remdesevir unless you are a very seasonedd medicinal chemist with the requisite expertise?
https://endpts.com/a-chinese-company-is-already-mass-producing-gileads-experimental-coronavirus-drug/
http://www.bright-gene.com/en/page.php?id=20
Go to CHina, visit the Brightgene pharmaceuticals and get a suitcase full of the drug and bring it back to the US. If stopped by customs, justify it by claiming it is for personal use!
Why is this even a question? I’ve never understood the delimma of using an untried drug for a mortally ill patient. Choices: DIE, or try a drug that MIGHT have adverse affects…..Hmmmmm. Such a hard decision. NOT.
I placed a comment earlier today. With the Hope that the FDA whold approve Remdesivir sooner than later. What I have seen in Response are Political blame and Legal Issues. We need to use every thing within are Arsenal to battle this virus. We need to put are personal views aside and come up with a Solution. As a World this Virus is affecting all us as a Human Race. Collectively we can find a plausible answer. So everyone’s option matters . Resolution is the answer. Not Division. Collectively as a Word. Solving this Problem will be easy. Stay alert and safe.✌️
Yes yes yes Joseph Tammaro! Well said
Absolutely right. I have no time for politics, nor for any politician who does.
Joseph Tamaro,
Did you watch the Coronavirus Whitehouse briefing today (the bit about hydrochloroquine and Zpak mentione by Trump)? Was that a political or scientific decision?
https://nymag.com/intelligencer/2020/03/trump-coronavirus-speech-caused-lupus-meds-shortage-report.html
I see huge PR issues and nightmare and even lawsuits!
1. FOI compelling disclosure of how previous requests were considered, who got them and why.
2. Why under 18-year olds for future requests since epidemiology clearly shows they don’t get very sick. Ditto for pregnant women since there is scant evidence for maternal trsnsmidsion.
3. FOI disclosure for each and every future compassionate use request and determination. What if Angela Merkel gets really sick and she asks Trump for help? She is certainly a senior with possible underlying medical conditions!
IMO whomever came up with this hurried and half-baked policy did not think everything through thus should resign!
FDA made error. Hopefully be reviewed at higher level quickly. This not disease involving less than 200,000. It going be 20 million plus. Gilead able to handle the volume alone and will they be socially responsible? Makes me question our government dedication to ALL its people. Hope Trump and WHO reads this.
Israel should give it to the US for free. Considering all the half trillion in foreign aid we provided them over the years. Not even mentioning all the industrial espionage they conducted against the US.
Gilead isn’t Israeli. I suggest you get your facts straight in more ways than one.