Remdesivir and Coronavirus…

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A temporary authorization for emergency use during the pandemic follows two successful clinical trials.

Jim Crumly

Jim Crumly(TMFSpeyside)
May 1, 2020 at 6:21PM

The U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Gilead Sciences (NASDAQ:GILD) to use its investigational antiviral drug remdesivir to treat COVID-19. President Trump made the announcement in the Oval Office along with Gilead Chief Executive Officer Daniel O’Day, and the FDA released a letter confirming the authorization.

Remdesivir hasn’t been formally approved to treat any disease, but today’s action by the FDA authorizes it for temporary use during the pandemic to treat hospitalized patients with severe COVID-19.

The FDA decision was based on a review of top-line data from two clinical trials. In a placebo-controlled phase 3 trial  conducted by the National Institute for Allergy and Infectious Diseases, 1,063 critically ill patients receiving remdesivir had an average recovery time of 11 days, compared with 15 days in the placebo group. Those receiving the drug also had a lower mortality rate, although the mortality result was not proven with statistical significance. Patients in Gilead’s own Simple-1 trial showed improvement as well, but that trial was for comparing two different durations of treatment and wasn’t placebo-controlled.

Gilead is donating its entire current supply of the drug at no cost, which amounts to enough to treat 140,000 patients, assuming a course of treatment lasting 10 days. The biotech company is racing to ramp up manufacturing capacity and has set a goal of producing 500,000 treatment courses by October and a million by December. The Simple-1 study, though, suggested that a 5-day course of treatment produced similar results as a 10-day course, so Gilead now believes it will be able to treat far more patients than it thought when it set those goals.

https://www.fool.com/investing/2020/05/01/fda-authorizes-gileads-remdesivir-for-covid-19.aspx

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Reuters/Reuters
April 29, 2020 21:11 pm

(April 29): Gilead Sciences Inc said on Wednesday its experimental antiviral drug, remdesivir, had met the main goal of a trial testing it in COVID-19 patients.

The trial was being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), and more details on the data would be provided at an upcoming briefing by the NIAID, Gilead said. 

https://www.theedgemarkets.com/article/gileads-remdesivir-meets-main-goal-trial-covid19-patients

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By SARAH OWERMOHLE

04/23/2020 01:48 PM EDT

A leading coronavirus drug candidate showed no benefit in results from a hotly anticipated clinical trial that were mistakenly posted to the World Health Organization’s website today.

The experimental drug, an antiviral called remdesivir, is being studied in several late-stage trials and has recently drawn praise from President Donald Trump after a sliver of early data from a different clinical trial leaked last week.

The draft documents posted to the WHO website — and then quickly removed — suggest that the drug did not help patients enrolled in a randomized clinical trial in China, and caused significant side effects in several people that led them to end treatment. More participants who received remdesivir died compared to those in the control group, although the difference between the two groups was not statistically significant.

Gilead thinks the results were mischaracterized because the study ended early due to low enrollment, spokesperson Sonia Choi said. “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.”

“We regret that the WHO prematurely posted information regarding the study,” Choi added.

The Financial Times first reported the mistakenly posted results. Gilead’s stock price dropped more than 7 percent in the hours after the news.

Multiple “phase III” remdesivir studies are still ongoing in the U.S., with early results from some expected this month.

https://www.politico.com/news/2020/04/23/who-gilead-coronavirus-drug-204749

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Remdesivir anti-viral trial reports ‘rapid recoveries’ for severe hospitalised coronavirus patients with ‘nearly all’ discharged within a week and only two deaths out of 125

  • University of Chicago recruited 125 COVID-19 patients – 113 with severe disease
  • It was part of Gilead Sciences clinical trials of experimental drug remdesivir 
  • Patients had daily remdesivir infusions and most saw symptoms ease in a week
  • Gilead Sciences Inc’s shares surged 16 per cent in after hours trading Thursday  
  • Learn more about how to help people impacted by COVID

By VANESSA CHALMERS HEALTH REPORTER FOR MAILONLINE

PUBLISHED: 01:40 BST, 17 April 2020 | UPDATED: 14:44 BST, 17 April 2020

https://www.dailymail.co.uk/news/article-8228223/Report-says-COVID-19-patients-respond-Gileads-remdesivir-shares-surge.html?ito=social-twitter_mailonline

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https://www.fiercebiotech.com/biotech/as-toll-death-surges-u-k-gilead-kickstarts-remdesivir-covid-19-trials-across-country

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https://cen.acs.org/biological-chemistry/infectious-disease/initial-remdesivir-data-tell-us/98/i13

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