U.S. emergency approval broadens use of Gilead's COVID-19 drug remdesivir

[rooster59]

U.S. emergency approval broadens use of Gilead's COVID-19 drug remdesivir

By Steve Holland

 

FILE PHOTO: Vials of investigational coronavirus disease (COVID-19) treatment drug remdesivir are capped at a Gilead Sciences facility in La Verne, California, U.S. March 18, 2020. Picture taken March 18, 2020. Gilead Sciences Inc/Handout via REUTERS/File Photo

 

WASHINGTON (Reuters) - Gilead Science Inc's <GILD.O> antiviral drug remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration for COVID-19 on Friday, clearing the way for broader use of the drug in more hospitals around the United States.

 

During a meeting in the Oval Office of the White House with President Donald Trump, Gilead Chief Executive Daniel O'Day called the move an important first step and said the company was donating 1.5 million vials of the drug to help patients.

 

The donation is expected to be enough for at least 140,000 patients, depending on the number of days they need to be treated.

 

Gilead said on Wednesday the drug, which is given by intravenous infusion, had helped improve outcomes for patients with COVID-19, the respiratory disease caused by the novel coronavirus, and provided data suggesting it worked better when given earlier in the course of infection.

 

With many countries reeling from the coronavirus pandemic, interest in Gilead’s drug has been high because there are currently no approved treatments or preventive vaccines for COVID-19. Doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in extremely severe cases.

 

Data released this week from a trial by the National Institutes of Health (NIH) in the United States showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment, but did not significantly improve survival.

 

Gilead did not immediately respond to a request for the price it plans to charge for the drug after its pledged donations are used up. The Institute for Clinical and Economic Review, which assesses effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at $10, but suggested that the price would rise to $4,500 based on patient benefits shown in clinical trials.

 

Remdesivir was previously available only for patients enrolled in clinical trials or for patients cleared to get the drug under expanded use and compassionate use programs. Through Gilead's trials, more than 181 hospital locations around the world, including hospitals in 27 U.S. states, have been administering the drug.

 

The FDA authorization applies to patients hospitalized with severe COVID-19 who require oxygen supplementation.

 

U.S. Vice President Mike Pence said the 1.5 million vials would start being distributed to hospitals on Monday.

 

Gilead said the federal government will coordinate the donation and distribution of remdesivir to hospitals in cities hardest hit by COVID-19. Citing the drug's limited supply, the company said hospitals with intensive care units and other hospitals that the government deems most in need will receive priority.

 

There have been more than 3.2 million people infected by the novel coronavirus worldwide and over 232,800 dead, according to a Reuters tally.

 

The United States has the most cases and casualties at more than 1 million and at least 63,200 with much of the country in lockdown to contain the spread of the virus.

 

The recent clinical data has raised hopes remdesivir might be an effective treatment.

 

A draft study abstract released inadvertently by the World Health Organization (WHO) last week said remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. The drugmaker said the findings were inconclusive because the study was terminated early.

 

Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the new coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.

 

(Reporting by Steve Holland, additional reporting by Deena Beasley in Los Angeles and Carl O'Donnell in New York, writing by Jeff Mason; Editing by Grant McCool)

 

-- © Copyright Reuters 2020-05-02

 

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[Slip]

Let us hope it is effective.  It can hardly be worse than drinking or injecting bleach.

[Toany]

Who says no benifit, but look at the mark up in cost to make and likely sale price.  I expect in years or months to come we will find out the side effects.  The world is in panic mode and will clutch at any straw

[ChouDoufu]

this is concerning.  change the measuring stick during the trial so you can announce a success?  maybe good reasons for the change, but still would like to think death of the patient would be a top consideration for a miracle drug.

 

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

 

https://www.msn.com/en-us/news/us/government-researchers-changed-metric-to-measure-coronavirus-drug-remdesivir-during-clinical-trial/ar-BB13ui2k

[Toany]

$10 to make sell for $4,500.  That what I call a healthy profit margin.  Maybe tRump has shares

[Tug]

We will know in a few weeks how good it really is going to take time to build the data I hope it really kicks covid ass!!

[rabas]

2 hours ago, ChouDoufu said:

this is concerning.  change the measuring stick during the trial so you can announce a success?  maybe good reasons for the change, but still would like to think death of the patient would be a top consideration for a miracle drug.

 

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

 

https://www.msn.com/en-us/news/us/government-researchers-changed-metric-to-measure-coronavirus-drug-remdesivir-during-clinical-trial/ar-BB13ui2k

From your link. "The change reflects evolving scientific understanding of the fast-moving nature of the virus and uncertainties around how the lethal effects reveal themselves in patients, said NIAID, Gilead, and outside specialists."

 

Looks like everyone agrees. The reason was because deaths due to underlying conditions unrelated to nCoV2019 would obscure the effects of the drug.  From a scientific reference. Many trials are showing similar good results but they are not using the same placebo control groups. 

 

Still not a knock out. A knock out may not be easy considering how viscous this brand new virus is. Emerging reports show that many young people in good health are suffering large vessel strokes. Ouch. Your entire vessel system has ACE2 receptors.

 

Edited May 2, 2020 by rabas

[jollyhangmon]

1 hour ago, Toany said:

$10 to make sell for $4,500.  That what I call a healthy profit margin.  Maybe tRump has shares

 

... indeed, especially if you know & consider that UAB (see linked article) as well as NIH (National Institutes of Health) developed & researched this drug with plenty of public funding!!

Truly a fcuked up system if I ever saw one ... 

 

https://www.uab.edu/news/health/item/11082-investigational-compound-remdesivir-developed-by-uab-and-nih-researchers-being-used-for-treatment-of-novel-coronavirus

 

[ChouDoufu]

2 hours ago, rabas said:

From your link. "The change reflects evolving scientific understanding of the fast-moving nature of the virus and uncertainties around how the lethal effects reveal themselves in patients, said NIAID, Gilead, and outside specialists."

 

Looks like everyone agrees. The reason was because deaths due to underlying conditions unrelated to nCoV2019 would obscure the effects of the drug.  From a scientific reference. Many trials are showing similar good results but they are not using the same placebo control groups. 

 

Still not a knock out. A knock out may not be easy considering how viscous this brand new virus is. Emerging reports show that many young people in good health are suffering large vessel strokes. Ouch. Your entire vessel system has ACE2 receptors.

 

does everyone agree?  not if you read the entire article. 

 

the "everyone" you mention from the article includes "NIAID, Gilead, and outside specialists."  by "outside specialists," i would infer hand-picked experts for hire recommended by lobbying firms.  there are opposing voices further down in the article.

 

good news if it works as well as hoped and doesn't cause more misery.  in that case the government dodged a bullet.  but watching how our reality teevee government conducts business based on "better ratings than the final episode of the bachelor," i'm skeptical.  it gives the impression that while all other (as far as we know) clinical trials are following the recommended procedures, we're changing the rules to get there first, regardless of the consequences, and claim "winning"!

 

we certainly do need a win after our stable genius pushed hydroxycholoriqine and bleach injections and bringing uv bulbs into the body.

[Sheryl]

2 hours ago, Tug said:

We will know in a few weeks how good it really is going to take time to build the data I hope it really kicks covid ass!!

 

The data so far does not indicate anything of that magnitude.

 

It just shortens recovery time.

 

Research into possible uses for prevention or for mild cases is needed. At this point approved only for severe cases in hospitals.

[simple1]

1 hour ago, Sheryl said:

 

The data so far does not indicate anything of that magnitude.

 

It just shortens recovery time.

 

Research into possible uses for prevention or for mild cases is needed. At this point approved only for severe cases in hospitals.

May I add the full quote from the OP for clarity...

 

Data released this week from a trial by the National Institutes of Health (NIH) in the United States showed that remdesivir reduced hospitalization stays by 31% compared to a placebo treatment, but did not significantly improve survival.

[Oxx]

7 hours ago, Toany said:

$10 to make sell for $4,500.  That what I call a healthy profit margin.

 

Methinks you vastly underestimate the rapaciousness of the American pharmaceutical industry.  Another drug, Truvada, costs around $72/year outside the United States for a generic version, whilst Gilead charges $20,000/year for it in America.

 

Source:  https://www.ft.com/content/6d034853-9fa3-41b6-a930-900f57629970

[Stargeezr]

Well I used to see new drugs from the USA have death as a side effect, and wonder

what the H are they trying to sell in the USA anyway. If they are desperate because

they have the most cases and deaths already I guess this drug will hopefully at

least help the situation a little bit. As someone said better than bleach or poison.

Geezer