FDA authorizes the drug remdesivir for emergency use in COVID-19 patients

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The Muslim Times has the best collection for war against Covid 19. Publication of Remdesivir trial in New England Journal of Medicine: NEJM study about Remdesivir

FDA authorizes experimental drug remdesivir for emergency use in COVID-19 patients

Source: The Verge

The Food and Drug Administration just authorized the emergency use of remdesivir, an experimental antiviral drug, to treat COVID-19.

Emergency authorization does not mean that the drug is FDA-approved, a standard that only comes after a detailed review showing that a drug can safely and effectively treat a particular disease. The agency can issue an emergency use authorization (EUA) for unapproved medical products that may help treat a life-threatening disease when no approved alternatives are available, and that’s what it did here.

An EUA is not the same as FDA approval. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir.

We need final data from clinical trials included in an FDA application to determine whether remdesivir is safe and effective in treating or preventing #COVID19.

The authorization does not mean the drug was proven to work by the FDA’s usual benchmarks but that “the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products,” according to the agency’s authorization letter.

Under the authorization, the drug can be used to treat patients who are hospitalized with a severe enough case of the disease that they need to be given supplemental oxygen or placed on a ventilator.

Pharmaceutical company Gilead, which makes remdesivir, previously announced that it plans to give away its entire existing supply of the drug — enough to treat over 140,000 patients. Gilead said in a press release that the US government will be in charge of distributing remdesivir to hospitals, but it is still unclear when the company will start to ship the drug under the new authorization.

Research showing that remdesivir blocks the activity of the novel coronavirus in cells made it a leading candidate to treat it. Gilead originally developed the drug to treat Ebola. Prior to this authorization, doctors could treat COVID-19 patients with remdesivir by enrolling them in clinical trials or making individual requests to the drug company under the FDA’s compassionate use policy.

Data from clinical trials of the drug has been mixed. The National Institute of Allergy and Infectious Diseases (NIAID) said this week that patients in its study who were treated with remdesivir recovered from COVID-19 four days faster than patients who were given a placebo. Eight percent of the group given the drug died, compared to 11 percent of the placebo group. The NIAID said it will release more detailed data on the study, which included over 1,000 patients, later on, leaving the findings difficult to critically analyze at this point.

Anthony Fauci, director of the NIAID, called the results “good news.” “What it has proven is a drug can block this virus,” he said in the White House this week. Former FDA commissioner Scott Gottlieb had a more reserved take on the results. “Evolutionary, not revolutionary,” he tweeted.

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Categories: Health, The Muslim Times

10 replies

  1. Coronavirus disease 2019 (COVID-19): IV: Limited data available; dosing used in clinical trials: 200 mg as a single dose on day 1, followed by 100 mg once daily for a total duration of 5 to 10 days (Gilead 2020; NIH 2020a; NIH 2020b; NIH 2020c).

    Source: Drugs.com

  2. Source: Vox

    The US Food and Drug Administration on Friday granted an emergency use authorization to remdesivir, an experimental antiviral drug to treat the Covid-19 coronavirus.

    The authorization allows the drug to be distributed to doctors to administer to patients with severe disease, namely patients with low blood oxygen or those needing breathing assistance with a mechanical ventilator.

    Many health experts have had high hopes for the drug, which was initially developed by Gilead Sciences to treat the Ebola virus, and has since been used in experiments to treat the coronaviruses SARS and MERS. That early testing gave remdesivir a head start in the race for a treatment to Covid-19.

    But despite the release of some early study results this week, it’s still not clear how effective the drug is at fighting the virus, and more research is needed before it can be used as the default treatment.

    Remdesivir previously showed some success in animal models. Now, early results from a clinical trial at the National Institutes of Health show that Covid-19 patients who took remdesivir recovered 31 percent faster than those prescribed a placebo. An internal study from Gilead also found that the drug was just as effective over 5 days of use as it is over 10.

    Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters at the White House on April 29 that he thought the findings were significant.

    “This is really quite important,” he said. “This will be the standard of care.”

    But a randomized trial of the drug in China recently published in the Lancet found that there was no statistical benefit to taking the drug.

    Taken together, the studies highlight the need for more studies. Remdesivir may or may not work, but it’s hard to say based on the evidence available at this point.

    Trials haven’t revealed a clear answer about using remdesivir to treat Covid-19
    Remdesivir works by blocking the virus behind Covid-19, SARS-CoV-2, from copying its genetic instruction set, RNA. These instructions are written in a code made of molecules represented by the letters A, U, G, and C. Remdesivir is designed to mimic the molecule represented by A, adenosine.

    When the virus’ enzymes make copies of its RNA during an infection, it can take up remdesivir instead of adenosine. When it does, the copying process comes to a grinding halt, and with it, the infection. What makes this especially useful is that remdesivir can fool a virus, but a not a human cell, so it has a targeted effect.

    But how well does it work against SARS-CoV-2 in an actual human? That’s where the studies come in.

    The NIH trial, called the Adaptive COVID-19 Treatment Trial, included 1,063 patients. The results showed that the median time to recovery for patients who randomly received the placebo was 15 days, while the patients who received remdesivir has a median recovery time of 11 days. Remdesivir also lowered the mortality rate compared to the placebo group, from 11.6 percent to 8 percent.

    These results, however, are preliminary and the data behind them haven’t been revealed, let alone published in a peer-reviewed journal.

    “It’s difficult to know what to make of that,” said John Norrie, a professor of medical statistics at the University of Edinburgh. “It’s very unusual to say ‘We’ve found some good news but we can’t tell you what it is.’”

    Meanwhile, Gilead’s internal study examined 397 patients, dividing them into groups treated with remdesivir for 10 days and groups treated for 5 days and found little difference between them. That could be interpreted to mean that remdesivir is just as effective at a lower dose, so the drug can be distributed to more patients. But the study didn’t even include a placebo treatment group, making it harder to gauge the impact of the drug.

    The Lancet paper on the other hand was based on a true randomized controlled trial from Wuhan, China with 237 patients. The study was also peer-reviewed by other scientists. Initially, the authors wanted to include up to 450 patients, but the lockdown imposed in the city meant that patients stopped arriving.

    Norrie, who wrote a commentary article about the Wuhan study, noted that while the study’s design was robust, the findings were inconclusive: There was no statistically significant benefit to taking remdesivir. It may work, it may not.

    Eric Topol, director and founder of the Scripps Research Translational Institute, told Reuters that this study was one of the stronger pieces of research on remdesivir and it showed that its impact was lacking.

    “That’s the only thing I’ll hang my hat on, and that was negative,” he said. “It was expected to be a whopping effect. It clearly does not have that.”

    It’s a frustrating result, but Norrie said that the urgent need for a treatment to aid in a global pandemic shouldn’t be an excuse for weaker research. However, one way to speed up the process is to pool data from smaller trials around the world into one. “I strongly believe that our best chance of getting to the right decisions quickly is to share data,” Norrie said.

    The FDA observed in their announcement that “there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19.”

    Still, doctors have been using remdesivir to treat some Covid-19 patients under compassionate-use guidelines. These allow some patients to use experimental drugs if no other options are left.

    There are at least 19 studies on remdesivir around the world underway or in planning stages, some recruiting thousands of patients. It will be several months before they yield definitive answers, but they will bring the world closer to a working treatment.

    https://www.vox.com/2020/5/1/21243012/remdesivir-coronavirus-covid-19-fda-drug-gilead

  3. Quote-/The FDA observed in their announcement that “there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19.”

    Still no hope soon 😂 but we should appreciate them and be patient

  4. The US Food and Drug Administration issued an emergency-use authorization on Friday for remdesivir in hospitalized patients with severe Covid-19.

    The FDA said it issued the authorization based in part on the results from a trial sponsored by the National Institutes of Health, the results of which were announced by Dr. Anthony Fauci on Wednesday. The infused drug reduced the time of illness in some severely affected patients.

    What this means: An emergency-use authorization is a lower regulatory bar than full FDA approval, but it’s a sign that the FDA believes the benefits of a drug outweigh its risks in certain patients.

    The FDA limited its authorization of the drug to adults and children with suspected or laboratory-confirmed Covid-19 and severe disease. The drug is administered in a hospital setting via IV by a healthcare provider

    The CEO of Gilead Sciences, the maker of remdesivir, said in an open letter on Wednesday that the company’s existing supply of the drug could cover at least 140,000 treatment courses for patients with Covid-19.

    https://www.cnn.com/webview/us/live-news/us-coronavirus-update-05-01-20/h_481a2b4d55ccf4412c643218e8aca31e

  5. One of Bangladesh’s largest drugmakers, Beximco Pharmaceuticals, will start production this month of the experimental antiviral drug remdesivir, which has shown promise in fighting the new coronavirus, a senior company executive said on Tuesday.

    Remdesivir, a drug developed by Gilead Sciences, has grabbed attention as one of the most promising treatments for Covid-19, the respiratory disease caused by the novel coronavirus that has killed more than 250,000 people.

    US drug authorities granted emergency use authorisation last week, paving the way for its broader use across US hospitals, after Gilead provided data showing the drug helped to improve survival rates for Covid-19 patients.

    A vial of the drug Remdesivir
    A vial of the drug Remdesivir Photograph: Ulrich Perrey/AFP via Getty Images
    Beximco’s pricing indicates a course of remdesivir treatment could cost anywhere between $295 and $781 per patient in the south Asian country depending on the severity of the case, the number of vials required and the final pricing of the drug.

    The figures are a first indication of how the potentially life-saving drug will be priced, as countries around the world struggle to control the pandemic.

    Gilead has donated an initial batch of 1.5m vials of the drug to help patients in the United States, but has yet to announce its pricing.

    https://www.theguardian.com/world/live/2020/may/05/coronavirus-live-news-who-and-five-eyes-reject-chinese-lab-theory-as-global-deaths-pass-250000#block-5eb153e18f08357ffc61849c

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