*WHO's still pimping for that Big Vaccine; but its take on remdesevir, reconfirming what* *we already knew about it, is worth noting. *
*MCM* Gilead's remdesivir has 'little or no effect' on COVID-19 recovery or > mortality: WHO > by Arlene Weintraub <https://www.fiercepharma.com/author/arlene-weintraub> | > Fierce Pharma, > Oct 16, 2020 8:32am > https://www.fiercepharma.com/pharma/gilead-s-remdesivir-has-little-or-no-effect-covid-19-recovery-or-mortality-who > Remdesivir was one of four treatments tested in a World Health > Organization trial involving 11,266 COVID-19 patients in 30 countries. None > offered much benefit, the agency said. > > Gilead Sciences’ antiviral remdesivir got an emergency authorization from > the FDA to treat COVID-19 in May on the basis of a study showing the drug > cut the recovery time for hospitalized patients by 31%. But a new and much > larger study has reached a very different conclusion. > > The World Health Organization (WHO) released preliminary results from a > trial involving 11,266 COVID-19 patients in 30 countries who were treated > with one of four drug regimens, including remdesivir. The drug “appeared to > have little or no effect on hospitalized COVID-19” patients, as measured by > the need for ventilation, the length of hospital stay and overall > mortality, according to the study, which was posted > <https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1.full.pdf> (PDF) > on the journal preprint site medRxiv. > > Gilead lashed out shortly after WHO released the study results Thursday. > “We are concerned that the data from this open label global trial have not > undergone the rigorous review required to allow for constructive scientific > discussion, particularly given the limitations of the trial design,” Gilead > said in a statement > <https://www.gilead.com/-/media/gilead-corporate/files/pdfs/company-statements/gilead-statement-on-solidarity-trial-final-clean.pdf?la=en> > (PDF). > > The trial admitted a broad selection of patients, resulting in > heterogeneity that makes it “unclear if any conclusive findings can be > drawn from the study results,” the company added. > > The WHO trial, which is ongoing, is designed to rapidly evaluate emerging > COVID-19 treatments in large patient populations. *The newly released > data cover remdesivir as well as hydroxychloroquine, protease inhibitor > lopinavir and interferon. All four were determined to be of little use in > treating COVID-19.* > > The trial, called Solidarity, is “adaptive,” meaning it will shift along > with changes in COVID-19 care over time. Hydroxychloroquine > <https://www.fiercepharma.com/pharma/end-road-for-hydroxychloroquine-covid-19-as-novartis-nih-and-who-pull-out-trials> > and lopinavir > <https://www.fiercepharma.com/pharma-asia/does-abbvie-s-hiv-drug-kaletra-also-works-covid-19-maybe-not-nejm-study-finds> > were > dropped as they fell out of favor, according to the WHO study. The > organization intends to add emerging COVID-19 treatments, such as > monoclonal antibodies, in the future. > > Gilead expects remdesivir, which carries the brand name Veklury, to bring > in $3.5 billion this year. The company is so optimistic about the drug’s > uptake during the COVID-19 pandemic that in July it upped its total revenue > expectations for the full year to between $23 billion and $25 billion, up > from its previous forecast of $21.8 billion to $22.2 billion. And its > expansion plans for the product include testing an inhaled version of it in > patients who aren't hospitalized. > > Shortly thereafter, the FDA expanded > <https://www.fiercepharma.com/pharma/gilead-s-veklury-wins-expanded-fda-authorization-for-moderate-covid-19-patients> > its > authorization for remdesivir to include all hospitalized COVID-19 patients > regardless of the severity of their disease. That came after a phase 3 > trial showing moderately ill patients on a 5-day course of the drug were > 65% more likely to see improvements in their symptoms than were patients > who only got the standard of care. > > But the study was far from a slam dunk: The improvement was not > statistically significant for patients who took remdesivir for 10 days. > > More recently, remdesivir got a bit of free advertising from U.S. > President Donald Trump, after his personal doctor revealed > <https://www.fiercepharma.com/pharma/trump-takes-regeneron-s-investigational-antibody-cocktail-hours-after-covid-19-diagnosis-wh> > earlier > this month that he had been treated with the Gilead antiviral. > > In its study, WHO deemed its overall findings “unpromising” and enough to > “refute early hopes” that remdesivir *and the other drugs *would > significantly affect outcomes in COVID-19. The main need going forward, the > authors wrote, “is for better treatments.” > --- Support News from Underground: http://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: http://archives.simplelists.com/nfu
