Coronavirus

FDA To Announce Emergency Use Authorization for Antiviral Remdesivir as COVID-19 Treatment

Promising randomized controlled trial results indicate the drug shortens time to recovery

|

The antiviral drug remdesivir will be given an emergency use authorization as a treatment for COVID-19 by the Food and Drug Administration (FDA) shortly, reports The New York Times. Gilead Science, the maker of the compound, noted in a press release earlier today that it was "aware of positive data emerging from the National Institute of Allergy and Infectious Diseases' (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing."

Apparently, that briefing may occur at the White House later today with President Trump and Dr. Anthony S. Fauci, the head of the NIAID.

The Times reports that Fauci said that the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third.

"Although a 31 percent improvement doesn't seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus," Dr. Fauci said. "This is very optimistic."

Mr. Trump called that a good sign. "Certainly it's a positive, it's a very positive event," he said.

In addition, Gilead Sciences reported that an open-label observational trial found that five days of treatment with the intravenous drug for COVID-19 was essentially as effective as 10 days.

Scott Gottlieb, the former commissioner of the FDA, told the biomedical news site STAT that "remdesivir isn't a home run but looks active and can be part of a toolbox of drugs and diagnostics that substantially lower our risk heading into the fall."

An earlier Chinese study reported that remdesivir was no more effective than placebo in treating severe cases of COVID-19. However, that study did note that patients treated earlier in the course of the disease did seem to fare somewhat better.

Using the drug to treat patients earlier in the course of their disease may result in better outcomes. "We know that with most antiviral medications the earlier you give it the better it is," said Boston Medical Center researcher Nahid Bhadelia to STAT. She suggested that means that treatment with the drug will likely be most effective in patients who have been infected more recently. "What will be important is that we find people on the outpatient side," Bhadelia said. "Again, testing becomes important, we want to have them come to the hospital as soon as possible."

A hopeful result, if still not an anti-COVID-19 silver bullet.

Advertisement

NEXT: The National Labor Relations Board Wants To Punish a Conservative Publisher for a Joke About Unions

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. //A hopeful result, if still not an anti-COVID-19 silver bullet.//

    The fact that Bailey continues to publish “scientific” articles analyzing the efficacy of prospective treatment options for SARS-COV-2 against an imaginary “silver bullet” standard is embarrassing.

    1. Testing is the only silver bullet!
      More testing!
      Test and test and test again!

    2. Change Your Life Right Now! Work From Comfort Of Your Home And Receive Your First Paycheck Within A Week. No Experience Needed, No Boss Over Your Shoulder…iou. Say Goodbye To Your Old Job! Limited Number Of Spots Open…
      Find out how HERE……More here

    3. Whine! Whine! Whine! All day long. Every day.

  2. It would be interesting to see if the most at-risk could take remdesivir as a prophylactic. Given the existence of PrEP (https://www.cdc.gov/hiv/basics/prep.html) it’s not unprecedented. Side effects might be a concern, though.

    1. That’s not how the drug works.

      1. The drug works by inhibiting the viral RNA polymerase. It is entirely plausible that by having the drug in your system, the virus is prevented from replicating enough to even cause infection. I’m not asserting it’s true, but given that the same thing seems to work for HIV (albeit for reverse transcriptase), it is not beyond the pale.

        1. Metazoan…You really want to sit for that 1 hour infusion for 9 to 10 days in a row?

          1. No, but there could be a dosing schedule that makes sense. Consider that chemotherapy patients take home a pump. It wouldn’t be something for everyone to take, just the most at-risk.

    2. Could use Hydroxychloroquine and Zinc as a preventive, but that wouldn’t make Big Pharma a gazillion dollars.

      Note that in a *free* country, we’d be free to self medicate.

      Funny how a freedom that limits corporate rent-seeking profits isn’t promoted by a “libertarian” magazine.

  3. Baily should sound the alarm! If this works white males will get credit! The only thing worse than a global pandemic is if a wite male solves the problem. We need to find a multi-ethnic gay transgender person to give the credit to.

    1. Can’t they just use multi colored dyes on the capsules?

      1. No, but they could stamp the vials with rainbows….

    2. Only racists are obsessed with whether or not white males do or do not get credit for something.

  4. And because Trump said it was a positive thing, CNN and MSNBC headlines: “Trump forces people to drink remdesivir while condemning the other 69% to certain death”.

    When the Biden campaign was asked for his statement on remdesivir, Biden was said to have fought off gangster Cornpop while inventing the stuff in the 60s, and would comment further as soon as he found his pants.

  5. Wait… but chinese studies dismissed this drug as well as the fish tank cleaner. We are still going to trust the Chinese study foremost on the latter right Ronnie?

    1. Fish tank cleaner isn’t under patent. Drugs lose safety and effectiveness w/o IP.

      1. “Drugs lose safety and effectiveness w/o IP.”

        Literally true according to FDA approved trials.

  6. >>if still not an anti-COVID-19 silver bullet.

    food chain has us looking up @viruses, no?

  7. Glad we’re gettin all hyped up over flu season. Every year more Americans die from viruses than were killed in Vietnam.

    And even more die from heart disease, strokes, liver disease, and diabetes. But let’s all cower in fear in our homes anyway.

  8. Mr. Bailey…You’re the science guy. May I suggest that whenever you write an entire article about a single drug, you include: dosage, route of administration, mechanism of action and side effects. You could take a stab at actually educating us…

    1. Peasants don’t need to be educated. Just told what to believe.

      1. Ah, you set me straight. Silly me, what was I thinking? 🙂

  9. “What will be important is that we find people on the outpatient side,”

    Focusing on treating people who aren’t sick enough to be hospitalized seem like cheating.

    Are there any figures on critical and fatal cases of corona among those taking aquarium cleaner for lupus, arthritis, malaria etc?

  10. Mr. Trump called that a good sign. “Certainly it’s a positive, it’s a very positive event,” he said.

    Welp, that’s the end of that. All the best experts, the ones that get quoted by the NYT and CNN, are unanimously agreed there is no such thing as remdesivir, its effectiveness has been thoroughly and repeatedly debunked, people are going to die from trying to make homemade remdesivir from Drano and shoe polish, and this is all just more proof that Trump is clinically insane.

  11. Personally, I’ve never cared for Coors Light.

  12. Seems strange that there is such a big concern about hospital space when there is no actual treatment for it.

    So basically, they just watch patients and plug them into a ventilator if needed eventually?

  13. how much are the makers of Remdesivir paying Trump to not mention their product as a cure. it must be in the millions

Please to post comments

Comments are closed.