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Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed, found last week the drug did not increase the chances of survival or result in faster recovery.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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Anti-viral drug remdesivir effective against coronavirus, study finds

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Anti-viral drug remdesivir cuts recovery times in coronavirus patients, according to the full results of a trial published Friday night, three weeks after America’s top infectious diseases expert said the study showed the medication has “clear-cut” benefits.

Complete results from the research, which was carried out by US government agency the National Institute of Allergy and Infectious Diseases (NIAID), were published by leading medical periodical the New England Journal of Medicine.

The United States authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering following suit.The study found that remdesivir, injected intravenously daily for 10 days, accelerated the recovery of hospitalized COVID-19 patients compared to a placebo in clinical tests on just over a thousand patients across 10 countries.

On April 29, NIAID director Anthony Fauci, who has become the US government’s trusted face on the coronavirus pandemic, said preliminary evidence indicated remdesivir had a “clear-cut, significant and in diminishing the time to recovery.”The National Institutes of Health, of which the NIAID is a part, said Friday in a statement online that investigators found “remdesivir was most beneficial for hospitalized patients with severe disease who required .”

But the authors of the trial wrote that the drug did not prevent all deaths.”Given high mortality despite the use of remdesivir, it is clear that treatment with an anti-viral drug alone is not likely to be sufficient,” they said.About 7.1 percent of patients given in the trial group died within 14 days—compared with 11.9 percent in the placebo group.

However, the result is just below the statistical reliability threshold, meaning it could be down to chance rather than the capability of the .

A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12).

As compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).

Conclusions

Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705. opens in new tab.)

Source: https://medicalxpress.com

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