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Posted by: thepinetree on 10/22/2020 02:44 PM Updated by: thepinetree on 10/22/2020 02:44 PM
Expires: 01/01/2025 12:00 AM
:

FDA Approves First Treatment for COVID-19

Washington, DC...Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.





This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. This is different from the standard used in the issuance of an EUA.

The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.

A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days (n=191) and treatment with Veklury for 10 days (n=193) with standard of care (n=200). Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different.

A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days (n= 200) and treatment with Veklury for 10 days (n= 197). Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.

Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. Similar safety information about using Veklury to treat COVID-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and patients/caregivers.

The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats.

The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###


Comments - Make a comment
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No Subject
Posted on: 2020-10-22 14:59:33   By: Anonymous
 
I wonder how many shots kamala has had for Diseases?

[Reply ]

    Re:
    Posted on: 2020-10-22 15:24:30   By: Anonymous
     
    Tonight’s debate looks like Tony’s going to correct some of joe Biden’s lies! Perhaps explain hunters piggy bank from China. Gonna be interesting indeed. Already voted for Trump so this will add icing to the cake!

    [Reply ]

      Re:
      Posted on: 2020-10-22 15:33:07   By: Anonymous
       
      What about Trump’s actual Chinese bank account? Who gave him $17 million in his first year as president?

      Since he's the president, not a private citizen.

      [Reply ]

        Re:
        Posted on: 2020-10-22 15:43:39   By: Anonymous
         
        It was an insurance payment. Don't you look or try to search anything besides liberal, right bashing sites?
        A disgruntled democrat for idiots in my party.

        [Reply ]

          Re:
          Posted on: 2020-10-22 16:13:16   By: Anonymous
           
          Do not expect me to believe a 12 year old insurance payment showed up in China in 2017. That’s just BS.

          [Reply ]

          Re:
          Posted on: 2020-10-22 16:17:30   By: Anonymous
           
          And nobody believes your “I’m a democrat” either.

          [Reply ]

        Re:
        Posted on: 2020-10-22 15:52:40   By: Anonymous
         
        I haven't voted yet, I'm pretty sure I know who I'll vote for but I want to hear the debate.
        The first one I recorded, but after hearing part of it, an embarrassment.
        The VP one, Pence won, but he's known to be good and did a radio gig. Harris wasn't good at all, and her smirking made her look like quite the amature and in no way is she qualified. When you don't know where to stand on a subject, change your mind weekly depending on who you talk to, or you say one thing and your running mate who picked you, said the opposite? Ain't a good sign.
        But like I said, I'm listening to it all. Plus this Hunter hard drive, I want more confirmed from the FBI. So far I'd say Joe might have a problem, and his son is a huge one, really huge.

        [Reply ]

          Re:
          Posted on: 2020-10-22 16:14:47   By: Anonymous
           
          You are a rare, beautiful unicorn, dear undecided voter. 😂

          [Reply ]

            Re:
            Posted on: 2020-10-23 06:52:04   By: Anonymous
             
            Only an imbecile would vote before the debates. That's why so many Dems have voted already.
            Biden is ahead just like Hillary was.😉

            [Reply ]

              Re:
              Posted on: 2020-10-23 12:46:23   By: Anonymous
               
              Yes, how could anyone know they don’t like Trump already?

              [Reply ]

      Re:
      Posted on: 2020-10-22 16:16:37   By: Anonymous
       
      Hey - let's be fair here. One cannot point to Biden's kid without pointing out that Trump's kids are doing exactly the same thing. It began 3 years ago with the condo immigrant sham in China.

      [Reply ]

        Re:
        Posted on: 2020-10-22 16:19:03   By: Anonymous
         
        Or paying Ivanka consulting fees for a job she was already doing to write it off on his taxes.
        There are so many examples.

        [Reply ]

      Re:
      Posted on: 2020-10-22 17:24:44   By: Anonymous
       
      No wonder Trump fired Fauci, arrested for mushrooms and heroin! Unfortunately he’s a Democrat and had contacts in Arnold, believe it or not. Seems like losers stick together. Gonna take some serious time to right this ship!!

      [Reply ]

Fauci arrested
Posted on: 2020-10-22 15:10:27   By: Anonymous
 
I know you folks won't believe me, but today Fauci was arrested for illegal drugs. I swear to God he was, he seems to like psilocybin mushrooms, and heroin, at least that's what he was caught with.
I stake my honor on that, that is wha5 I read from a conservative site, and I'm a democrat, who going to vote for a Conservative.

[Reply ]

    Re: Fauci arrested
    Posted on: 2020-10-22 15:25:04   By: Anonymous
     
    🤣🤣🤣🤣🤣

    [Reply ]

      Re: Fauci arrested
      Posted on: 2020-10-22 15:38:03   By: Anonymous
       
      Sloppy Joe is going to look like the lying piece of sh*t that he really is. President Trump's special debate guest is a whistleblower named Tony who knows all about the Bidens and their corrupt scheme to receive millions from the Russians. This will definitely nail his coffin closed. LOL! LOL! LOL!

      [Reply ]

      FDA- Remdesivir Not A Covid Treatment
      Posted on: 2020-10-22 15:44:22   By: Anonymous
       
      Many Federal health agencies have been captured by the dump cabal.
      In trials verified by the FDA Remdesivir showed no therapeutic valve for Covid patients.

      It is sad how dump has corrupted our health agencies for monetary gain either for himself or his pals.

      dump is a con grifter who cares more for how to monetize the power of the office over human lives of Americans.

      He is a mass murderer of Americans. He has waged war on Americans. He is a domestic terrorist.

      [Reply ]

        Re: FDA- Remdesivir Not A Covid Treatment
        Posted on: 2020-10-22 16:24:33   By: Anonymous
         
        It can reduce the length of a hospital stay, but it’s nothing close to a “treatment”.

        [Reply ]

          Re: FDA- Remdesivir Not A Covid Treatment
          Posted on: 2020-10-22 17:49:16   By: Anonymous
           
          The WHO said Remdesivir is not effective for Covid treatment- no noted improvement in patients.

          A large study led by the World Health Organization suggests that the antiviral drug remdesivir did not help hospitalized COVID-19 patients, in contrast to an earlier study that made the medicine a standard of care in the United States and many other countries.


          [Reply ]

    Re: Fauci arrested
    Posted on: 2020-10-22 15:41:37   By: Anonymous
     
    It's true, here.
    When the driver awoke, he identified himself as 25-year-old Vincent Fauci of Long Barn who was on searchable probation. The deputy pulled down the visor to reveal a stun gun. And inside the box, he found separate clear baggies containing over 30 prescription pills, psilocybin mushrooms, and suspected heroin.

    MML

    [Reply ]

    Re: Fauci arrested
    Posted on: 2020-10-22 16:18:58   By: Anonymous
     
    You might want to re-read that story. I think you missed the bit about it NOT being the head of the National Institute of Allergy and Infectious Diseases

    [Reply ]

      Re: Fauci arrested
      Posted on: 2020-10-23 02:18:47   By: Anonymous
       
      IDIOT HILLBILLY TRUMPTURDS ARE IN DENIAL

      [Reply ]

      Re: Fauci arrested
      Posted on: 2020-10-23 08:09:07   By: Anonymous
       
      Oh gee, really? Huh? Who would of known? Golly Jeepers I sure though it was him. You know, like he wanted to take some time off and come back home up here, kick back, relax, shoot up. Not many people know he has a get away place up here. That's probably his son, the one who takes kickbacks from China and WHO because they're corrupt. Yeah that's it, that's the ticket.
      (nothing gets by you does it?)


      [Reply ]


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