US Food and Drug Federation set to authorize new Covid-19 drug Archived Message Posted by walter on April 29, 2020, 11:00 pm Remdesivir now has the yellow jersey, which I expect to be passed around a lot in coming months. Good that something seems that it may help, albeit modestly. This is not a released study, but a preliminary data analysis. Some caution may be advised as corners were cut in the authorization process (authorized on one positive, unpublished study, wonder if that's a record). "A Chinese study was stopped early due to too few patients, so it was grossly underpowered." I hope patients don't all start to demand it and inhibit the emergence of something better. ---------------------------------------------- Gilead’s remdesivir drug speeds up coronavirus recovery, slows deaths, major government study finds Most important and rigorous test shows faster recovery, fewer deaths By Lisa Krieger | PUBLISHED: April 29, 2020 at 10:33 a.m. | UPDATED: April 29, 2020 at 1:00 p.m. A government-run study of Gilead Science’s remdesivir, the most promising experimental drug to treat COVID-19, shows that it helps patients with advanced disease, shortening their illness and slightly reducing death rates. In long-awaited news, the National Institute of Allergy and Infectious Diseases announced on Wednesday morning that a preliminary data analysis shows that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received an inactive placebo. Specifically, that patients who received the drug made by the Foster City-based company had a 31% faster time to recovery than those who received placebo. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group. The U.S. Food and Drug Administration plans to announce as early as Wednesday an emergency use authorization for the drug, according to the New York Times. This is an easing of rules, due to the urgency of need, that would allow the drug to be used without formal and time-consuming federal review or approval. Meeting with reporters at the White House on Wednesday, NIAID Director Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, cautioned that the results still need to be properly peer reviewed. But he expressed optimism that it could help make a difference in speeding up the recovery of some patients “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” said Fauci, according to The New York Times. “This is very optimistic.” Until now, information about the drug has been leaked out in drips without sufficient data, with conflicting reports about the drug’s potential benefit. Many of the trials have been uncontrolled or poorly controlled. A Chinese study was stopped early due to too few patients, so it was grossly underpowered. But the government’s randomized, controlled trial involving 1063 patients, which began on February 21, is considered the gold standard of research. The trial, known as the Adaptive COVID-19 Treatment Trial, or ACTT, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. An independent data and safety monitoring board overseeing the trial met on April 27 to review data and shared their interim analysis with the study team, according to NIAID. The trial closed to new enrollments on April 19. Based upon their review of the data, they noted that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level. More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report, according to NIAID. At Stanford Medicine, one of many medical centers around the world in global trials of remdesivir, the team of infectious disease scientists say they picked the drug as their first choice in early March, based on promising results from years of lab and animal research. “We brought this on fast,” said Dr. Aruna Subramanian, clinical professor of infectious disease and co-principal investigator of a Gilead trials at Stanford, in a prepared statement. “We got everything together in a week and were ready to roll. This was record time. This type of thing normally takes two to three months to get on board.” Remdesivir patient Monica Yeung-Arima of Palo Alto received the drug while hospitalized for 13 days at Stanford Hospital in early March. Yeung-Arima received intravenous infusions for five days. Three days later, she began to feel better. “I am so glad that I could be one of the ‘guinea pigs,’ ” she said. “Even if it’s not a 100% cure, it will put many people at ease to have a solution,” she said. “I’m so glad that there’s positive news and the drug can possibly be used in many patients soon.” Now, nearly two months after becoming infected on a Nile River cruise, she is back to her normal routine, although she still has chest congestion and an intermittent cough. Also on Wednesday, Gilead said that a different trial showed that patients who were given the drug earlier showed a faster response to treatment. This study involved 397 patients with severe cases of COVID-19 who were divided into two groups and given remdesivir in five- and 10-day dosage regimens. While patients in both groups showed improvements in the symptoms, those who were given remdesiver sooner exhibited a a quicker response to the treatments. Gilead said 64.5% of patients that were given the five-day treatment were discharged from the hospital within 14 days, compared to 53.8% of patients on the 10-day remdesivir course. There is currently no treatment for the illness, called COVID-19, which has spread globally. Of all the drugs now under investigation for COVID-19 treatment, remdesivir is one that makes the most biological sense. It incorporates itself into the viral genetic code, interrupting reproduction. In animals and cell cultures, it has killed the pathogens MERS and SARS, which are genetically similar to the new virus. Gilead, which specializes in antiviral drugs, found it by “screening” the company’s vast library of chemical compounds, an approach that is revolutionizing drug discovery. Companies spend a lot of money building these libraries, then test promising compounds on different cells or molecules to see if they are a “hit” for a certain disease target. Most hits go nowhere. The company hoped it would work during the West African Ebola outbreak of 2013 to 2016. But as an Ebola drug, it was a flop. Now the drug has been repositioned as a treatment for coronaviruses. The reason that repurposed drugs like remdesivir could be a good tool for fighting the virus is because they have already been through safety trials, which confirm that taking the medicine is not going to cause death on its own. The other important factor is that these drugs are already in production. There may be challenges in scaling up the manufacturing to meet the demand, but at least the basic infrastructure is there. Not everyone is eligible to participate in a clinical trial like this one. After giving away the drug to hundreds of ineligible – but critically ill — patients under an emergency “compassionate use” program, Gilead shifted to a new distribution strategy. It now has a new pipeline called “expanded access,” which will distribute the drug to large groups of sick patients through specific hospitals. The first trial participant in the NIAID trial was an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan, and volunteered to participate in the study at the first study site, the University of Nebraska Medical Center/Nebraska Medicine, in February 2020. A total of 68 sites, including Stanford University, ultimately joined the study. Of these sites, 47 are in the United States and 21 in countries in Europe and Asia. Correspondent Ariana Remmel and Business reporter Rex Crum contributed to this article. https://www.santacruzsentinel.com/2020/04/29/anti-viral-drug-accelerates-recovery-from-advanced-covid-19-says-niaid/ Message Thread: US Food and Drug Federation set to authorize new Covid-19 drug - walter April 29, 2020, 11:00 pm FDF? :-) nm - Shyaku May 1, 2020, 4:32 am   Searching