Another way to bury HCQ. (Thank you, Pres. Trump!)
FDA OKs Remdesivir, First Drug for COVID-19— Approval comes a week after > WHO trial showed no survival benefit > > by Ian Ingram <https://www.medpagetoday.com/people/ii1250/ian-ingram>, > Deputy Managing Editor, MedPage Today October 22, 2020 > https://www.medpagetoday.com/infectiousdisease/covid19/89281 > > The FDA approved remdesivir (Veklury) on Thursday > <https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19> > for > treating hospitalized COVID-19 patients, a first for the disease that > started a global pandemic. > > Remdesivir, an antiviral that works by limiting SARS-CoV-2 replication, is > indicated for hospitalized patients age 12 and up (and at least 40 kg [88.2 > lbs]). Previously, the intravenous drug was solely available under an > emergency use authorization (EUA) from the agency. > > FDA also announced a new EUA for remdesivir in hospitalized kids age 12 > and older weighing at least 3.5 kg (7.7 lbs) but less than 40 kg, and in > kids under age 12 weighing at least 3.5 kg. > > The news comes exactly a week after a major international trial led by the > World Health Organization (WHO) found no survival improvement > <https://www.medpagetoday.com/infectiousdisease/covid19/89167> for > hospitalized COVID-19 patients treated with the drug, and no improvement in > time to recovery. > > Approval was based on three randomized trials, including the National > Institutes of Health-led ACTT-1 trial > <https://www.medpagetoday.com/infectiousdisease/covid19/86670>, a phase > III trial that showed that patients with mild, moderate, and severe disease > who were treated with up to 10 days of remdesivir recovered a median 5 days > quicker than those on placebo (10 vs 15 days; rate ratio [RR] 1.29, 95% CI > 1.12-1.49, *P*<0.001), and a median 7 days quicker in those requiring > oxygen at baseline (11 vs 18 days; RR 1.31, 95% CI 1.12-1.52). > > Fewer patients on oxygen at baseline progressed to mechanical ventilation > or extracorporeal membrane oxygenation with remdesivir (13% vs 23%), and a > trend toward lower day-29 mortality was observed with the drug (11.4% vs > 15.2%; HR 0.73, 95% CI 0.52-1.03). > > "The approval of Veklury marks an important milestone in efforts to help > address the pandemic by offering an effective treatment that helps patients > recover faster and, in turn, helps preserve scarce healthcare resources," > ACTT-1 investigator Barry Zingman, MD, of the Albert Einstein College of > Medicine and Montefiore Medical Center in New York City, said in a press > release > <https://www.gilead.com/news-and-press/press-room/press-releases/2020/10/us-food-and-drug-administration-approves-gileads-antiviral-veklury-remdesivir-for-treatment-of-covid19> > from > drugmaker Gilead Sciences. > > "The availability of a rigorously tested treatment that can significantly > speed recovery and offers other benefits such as lower rates of progression > to mechanical ventilation, provides hospitalized patients and their > families important hope and offers healthcare providers a critical tool as > they care for patients in need," added Zingman. > > "Today's approval is supported by data from multiple clinical trials that > the agency has rigorously assessed and represents an important scientific > milestone in the COVID-19 pandemic," said FDA Commissioner Stephen Hahn, > MD, in the agency's announcement. > > Other trials that supported approval showed that a 5-day course of the > drug was roughly equivalent to a 10-day course > <https://www.medpagetoday.com/infectiousdisease/covid19/86710>, and that some > clinical benefit was also seen in patients hospitalized with moderate > illness <https://www.medpagetoday.com/infectiousdisease/covid19/88216>. > > Remdesivir is contraindicated in those allergic to the drug or any of its > components. Adverse events that were more common with the drug versus > placebo included nausea and increased liver enzymes, but FDA listed other > possible side effects that included allergic reactions, low blood oxygen > level, fever, shortness of breath, wheezing, swelling, rash, nausea, > sweating, and shivering. > --- Support News from Underground: https://bit.ly/NFUSupport Visit News from Underground: https://markcrispinmiller.com You received this email because you are subscribed to News from Underground. To unsubscribe from this email list, please go to: http://www.simplelists.com/confirm.php?u=pIdjNUgiG2h8yxbhC54SSy4SEskAoEMs For archives, please go to: https://archives.simplelists.com/nfu
