FDA Approves Remdesivir For Covid-19 Treatment

The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.

Key Facts

The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.

Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.

The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.

Clinical trial data has been mixed: A randomized trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed, found last week the drug did not increase the chances of survival or result in faster recovery.

Gilead shares jumped 3.8% in after hours trading following the announcement. 

Crucial Quote

“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead CEO Daniel O’Day in a statement.

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Key Background

President Donald Trump took remdesivir when being treated for the coronavirus earlier this month. Follow me on Twitter. Send me a secure tipRachel SandlerI’m a San Francisco-based reporter covering breaking news at Forbes. I’ve previously reported for USA Today, Business Insider, The San Francisco Business Times and San Jose Inside. I studied journalism at Syracuse University’s S.I. Newhouse School of Public Communications and was an editor at The Daily Orange, the university’s independent student newspaper. Follow me on Twitter @rachsandl or shoot me an email rsandler@forbes.com.

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Remdesivir is a prodrug of an adenosine triphosphate (ATP) analog, with potential antiviral activity against a variety of RNA viruses. Upon administration, remdesivir, being a prodrug, is metabolized into its active form GS-441524. As an ATP analog, GS-441524 competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription and decreases viral RNA production.

Remdesivir has an FDA Emergency Use Authorization for use in adults and children with suspected or confirmed COVID-19 in hospital with an SpO2 ≤94%.[L13239] This is not the same as an FDA approval.[L12609] The FDA Emergency Use Authorization suggests a loading dose of 200mg once daily in patients ≥ 40 kg or 5 mg/kg once daily in patients 3.5 kg to less than 40 kg, followed by a maintenance dose of 100mg once daily in patients ≥ 40 kg or 2.5 mg/kg once daily in patients 3.5 kg to less than 40 kg.[L13239] Patients not needing invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should be treated for 5 days (including the loading dose on day 1), up to 10 days if they do not show improvement.[L13239] Patients requiring invasive mechanical ventilation or ECMO should be treated for 10 days.[L13239]

Clinical trials used a regimen of 200mg once daily on the first day, followed by 100mg once daily for another 9 days.[A191931,L12174,L12177] Early data suggests that some patients may benefit from only 5 days of treatment.[A198810] Remdesivir was originally investigated as a treatment for Ebola virus, but has potential to treat a variety of RNA viruses.[A191379] Its activity against the coronavirus (CoV) family of viruses, such as SARS-CoV and MERS-CoV, was described in 2017,[A191382] and it is also being investigated as a potential treatment for SARS-CoV-2 infections.[A191427,A193254]

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CNBC Television 1M subscribers The FDA has approved Gilead’s Remdesivir as a Covid-19 treatment. Previously, the drug was approved only for emergency authorization. Gilead stock was up 4 percent after the news. Meg Tirrell joins ‘Closing Bell’ to discuss. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. The News with Shepard Smith is CNBC’s daily news podcast providing deep, non-partisan coverage and perspective on the day’s most important stories. Available to listen by 8:30pm ET / 5:30pm PT daily beginning September 30: https://www.cnbc.com/2020/09/29/the-n… Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBChttps://www.cnbc.com/select/best-cred…#CNBC

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Final Results In Remdesivir Trial Confirm It Shortens Length Of Covid-19 Cases, But Has Small Impact On Death

Topline

A long-awaited study of Gilead Sciences’ experimental antiviral remdesivir published Thursday in the New England Journal Of Medicine shows that patients with Covid-19 who took the drug recovered from the disease faster compared to patients who took a placebo.

Key Facts

The trial, which was led by the National Institute of Allergy and Infectious Diseases (NIAID), was double-blinded and involved more than 1,000 Covid-19 patients from around the world.

The trial  found that hospitalized patients who took remdesivir recovered from the disease in 10 days on average, five days faster than those taking a placebo.

The greatest benefit occurred when remdesivir was given to patients early in their illness who were hospitalized and receiving supplemental  oxygen but not yet on a ventilator.

The researchers also say that the data suggests that remdesivir may prevent patients from getting more severely ill and needing more oxygen or ventilation.

While the study itself didn’t find a statistically significant reduction in death for patients taking remdesivir, a later analysis suggested a small benefit, finding that 11.4% of patients who took remdesivir died by day 29, compared to 15.2% of patients that took the placebo.

Key Background

While there is no drug approved yet to treat Covid-19, remdesivir has been a frontrunner for months. In May, after preliminary study results showed that it helped patients recover from Covid-19 four days faster than a placebo, the FDA issued an Emergency Use Authorization for remdesivir (brand name Veklury) to be used in hospitalized patients with severe Covid-19. In August the agency expanded the recommendation and said that remdesivir could be used for any patients hospitalized with Covid-19, no matter the severity of their symptoms. Last week, President Trump’s doctors announced that the president received infusions of remdesivir after his diagnosis of Covid-19. There is currently a global shortage of the drug, and Gilead has announced plans to manufacture 2 million treatment courses of the drug by December. 

Quote

“For patients who are hospitalized with Covid-19, the importance of speeding up recovery by five to seven days cannot be underestimated,” wrote Gilead CEO Daniel O’Day in an open letter published Thursday. “This represents a significant benefit in a disease where every day counts.”

Chief Critic

Overall, the final report does not change the preliminary conclusions,” wrote Joshua Niforatos, an emergency room physician at Johns Hopkins Hospital. “Based on the research to-date, for critically ill covid-19 patients, remdesivir is unlikely to change survival or the need for mechanical ventilation. The only drug to-date that has shown to improve mortality remains dexamethasone, a generic and inexpensive drug.”

What’s Next

Gilead will likely use the results of this study to apply for official FDA approval of remdesivir, which has never been approved by the agency before. If the FDA accepts the company’s application, it would be the first approval of a drug specifically to treat Covid-19.

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Leah Rosenbaum

Leah Rosenbaum

I am the assistant editor of healthcare and science at Forbes. I graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

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We regret that the WHO prematurely posted information regarding the study, which has since been removed. The investigators in this study did not provide permission for publication of results,” a Gilead spokesperson said in a statement to CNBC. “Furthermore, we believe the post included inappropriate characterizations of the study. Importantly, because this study was terminated early due to low enrollment, it was underpowered to enable statistically meaningful conclusions,” according to Gilead. “As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.” For more coronavirus live updates: https://www.cnbc.com/2020/04/23/coron… For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2JdMwO7 » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

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Gilead Testing Inhaled Form Of Remdesivir That Could Be Used To Treat Covid-19 Outside Hospital

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Gilead is launching a phase 1 clinical trial of an inhaled version of remdesivir, a drug used to treat Covid-19, that could be administered to patients outside of the hospital, it said in a statement released Wednesday.

KEY FACTS

Though there are no drugs approved by the FDA to treat Covid-19, Remdesivir is one of the more promising candidates and was granted an Emergency Use Authorization in May to treat patients with severe cases of the disease.

In the hospital remdesivir is given intravenously, but the new trial will test whether it is effective if breathed directly into the lungs.

The medication would be given to patients through a nebulizer, a device commonly used to treat asthma that turns liquid medication into a breathable mist.

 

If inhaled remdesivir is successful, it could be an at-home or doctor’s office treatment for patients who are not sick enough to need hospitalization, but still could benefit from medication.

The new trial will include approximately 60 adults, and will test first for safety and tolerability of the inhaled medication.

 

Key Quote

“Based on current scientific understanding, the upper respiratory tract is the most prevalent site of SARSCoV-2 infection early in disease,”  said Gilead’s Chief Medical Officer Merdad Parsey in a statement. “Delivering remdesivir directly to the primary site of infection with a nebulized, inhaled solution may enable more targeted and accessible administration in non-hospitalized patients.”

Background

While many medications have been tested to see if they can treat Covid-19, almost none have been successful so far. Some studies have shown that remdesivir, an antiviral medication developed by Gilead, can help patients recover faster from severe Covid-19 in the hospital — but more research still needs to be done. One study found that patients treated with remdesivir recovered from Covid-19 about four days faster than those treated with a placebo, and had a 7.1% risk of mortality compared to 11.9%. In early June, the U.S. received criticism for buying the world’s supply of the drug, leaving some to wonder what other countries would do if they need it for Covid-19 treatment. Late last month the pricing of remdesivir was revealed: private insurance companies in the U.S. will be charged $3,120 for a course of treatment, or $520 per vial.

Full coverage and live updates on the Coronavirus

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I am the assistant editor of healthcare and science at Forbes. I recently graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

Source: http://www.forbes.com

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U.S. Buys The World’s Supply Of Breakthrough Coronavirus Drug Remdesivir

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Alex Azar, United States Secretary of Health and Human Services boasted of President Trump’s “amazing deal” that has bought the world’s entire supply of Gilead Sciences’ Remdesivir, a drug that some research suggests could speed the recovery of coronavirus patients.

The U.S. government will buy 100% of the California-based pharmaceutical company’s production in July, 90% of output in August and September in a move that should provide enough Remdesivir to treat around 80,000 patients. The deal between the U.S. government and Gilead means that low and middle-income countries can make their own generic version of Remdesivir, but European, and other, countries will be unable to buy, or produce it. Remdesivir sells for $390 per vial, or $2,340 per course of treatment sparking a backlash from consumer groups over its pricing pointing to $70 million of U.S. taxpayers’ support for Gilead’s development of the drug.

 

Gilead in May donated its entire stockpile of the drug, which was originally developed to treat hepatitis and respiratory viruses, to the U.S. government but doctors have faced having to ration the limited supply for the most needy patients, according to CNN.

Early research shows that the drug speeds recovery time for patients severely ill with coronavirus to 11 days from 15 days for those in the control group.

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KEY QUOTE

“President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19,” said HHS Secretary Alex Azar in a statement. “To the extent possible, we want to ensure that any American patient who needs Remdesivir can get it.

Key background

The Federal Drug Administration authorized emergency approval in May for the antiviral drug in May after early research showed that it could help patients infected with coronavirus recover faster.

The battle for access to a potentially crucial treatment plays out against the backdrop of Europe’s recovery from the pandemic, a surge of new infections in the U.S., and President Donald Trump’s reflexive nativism. The Trump administration’s trade war and diplomacy has repeatedly taxed even some of the U.S’s most long standing alliances, and the White House’s attempt in March to lure German company CuraVac to produce a coronavirus vaccine exclusively for Americans with financial incentives caused uproar.

Tangent

The U.S. has been the world’s worst affected nation and as 47,000 new cases of coronavirus were reported on Tuesday, the worst single day since the start of the pandemic, according to the New York Times.

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I joined Forbes as the European News Editor and will be working with the London newsroom to define our coverage of emerging businesses and leaders across the UK and Europe. Prior to joining Forbes, I worked for the news agency Storyful as its Asia Editor working from its Hong Kong bureau, and as a Senior Editor in London, where I reported on breaking news stories from around the world, with a special focus on how misinformation and disinformation spreads on social media platforms. I started my career in London as a financial journalist with Citywire and my work has appeared in the BBC, Sunday Times, and many more UK publications. Email me story ideas, or tips, to iain.martin@forbes.com, or Twitter @_iainmartin.

Source: http://www.forbes.com

The US has bought up virtually all stocks of a drug shown to work against Covid-19 – raising fears Brits won’t be able to get hold of it until autumn. The decision by the Trump administration has sparked fury with leading scientists who have raised concerns over “fair access” to remdesivir. The anti-viral drug was originally developed for use against Ebola but trials showed that it helped patients hospitalised with coronavirus recover almost a third faster. Health Secretary Matt Hancock hailed it the “biggest step forward” in treating Covid-19 when it was given approval for use on the NHS in May.
But now there are concerns patients in the UK won’t get widespread access to the treatment after the US bought more than 500,000 doses. It makes up the entire global supply for July and 90 per cent of stocks for August and September. Read more Trump buys up ENTIRE stock of coronavirus drug remdesivir – sparking fury among medics https://www.thesun.co.uk/news/1199617…
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