@Lupposofi A couple of years ago, I coauthored a paper trying to measure the applicability of the #aducanumab (#Aduhelm)'s results applied to the real world practice of a #geriatric outpatient clinic (with special focus on older persons with #cognitive impairment). Less than 1% of patients were potentially eligible. And this on the top of the unclear/arguable effects...
drug over the last two years hasn’t been reported. And, no refunds are being offered.
We all remember the disastrous approval by the FDA of #Biogen's Alzheimer's drug is #Aduhelm, which was “rife with irregularities” and involved “lapses in protocol." The good news here is that the drugmaker is pulling the drug off the market...
#medicine #medtwitter #pharma #press By: Allsion DeAngelis https://www.statnews.com/2024/04/04/amylyx-to-pull-als-drug-relyvrio-from-market/
Smart medical folks I know said 3 years ago that the #FDA's conditional approval of #Aduhelm, an expensive drug of dubious value for #Alzheimers, was a mistake. They were right. https://www.nbcnews.com/health/health-news/biogen-stop-alzheimers-drug-aduhelm-rcna136619
An expected news from Alzheimer therapies, https://www.alzforum.org/news/community-news/adieu-aduhelm-biogen-stops-marketing-antibody
A bit nostalgic, though, because I was one of the few whose cognition improved (relatively, i.e. compared to the control-group) during the years I got the antibody 10 mg / kg, enough for Biogen to apply for license.
It was a marvellous box-seat to observe pharmaceutical research with all it's intricacies, and live neurological expertise within an arm's reach was invaluable.
Here is the history of aducanumab, rest in pieces, https://www.alzforum.org/therapeutics/aduhelm
Biogen dumps dubious Alzheimer’s drug after profit-killing FDA scandal - Enlarge / The exterior of the headquarters of biotechnology company Bio... - https://arstechnica.com/?p=2000435 #clinicaltrial #aducanumab #alzheimers #science #aduhelm #health #biogen #fda
Sorry, I’ve got to weigh in here. It is a good question but it will be years before we have anything resembling an answer. Today’s was an inevitable decision - baked into the cake when #Leqembi’s predecessor, #Aduhelm, was given the fast track by the FDA. Statistically significant but clinically meaningless slowing of #Alzheimer’s decline is not “improvement”; it is marketing. Personally, I am quite worried that there will be needless deaths. I hope I’m wrong.
Four senior #FDA leaders forged close ties with #Biogen ahead of #Aduhelm's approval. Now they've all left FDA. Three of those four senior officials, who managed and worked closely with the clinical and biostats reviewers assigned to the Aduhelm application, have now ended up working at drugmakers
https://endpts.com/four-senior-fda-leaders-forged-close-ties-with-biogen-ahead-of-aduhelms-approval-now-theyve-all-left-fda/ #revolvingdoor #quidproquo
House Committees Release Internal Documents from #FDA and Biogen Related to #Alzheimers drug #Aduhelm's Review & Accelerated Approval https://energycommerce.house.gov/newsroom/press-releases/maloney-and-pallone-release-staff-report-on-review-approval-and-pricing-of
"Biogen was prepared to spend up to several billion dollars — more than two-and-a-half times what it spent developing the drug — on aggressive marketing to counter expected 'pushback' over whether Aduhelm was worth its price." Damning article about FDA approval process for #Aduhelm https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html
#Aduhelm never should have been approved by the #FDA. This was a blatant case of #RegulatoryCapture. Of course #Biogen's credibility was damaged; they DESERVED for their credibility to be damaged.
#alzheimers #MediFedi #MedMastodon
(Free link, no paywall)
https://www.washingtonpost.com/science/2022/12/29/alzheimers-fda-biogen-aduhelm/?pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWJpZCI6IjI5Nzk3NjciLCJyZWFzb24iOiJnaWZ0IiwibmJmIjoxNjcyMzQzMzcxLCJpc3MiOiJzdWJzY3JpcHRpb25zIiwiZXhwIjoxNjczNTUyOTcxLCJpYXQiOjE2NzIzNDMzNzEsImp0aSI6ImY0MmNhN2ZiLTA0NTQtNGYzMC1iNTg4LTYwMzMwN2Y4N2JkZiIsInVybCI6Imh0dHBzOi8vd3d3Lndhc2hpbmd0b25wb3N0LmNvbS9zY2llbmNlLzIwMjIvMTIvMjkvYWx6aGVpbWVycy1mZGEtYmlvZ2VuLWFkdWhlbG0vIn0.J6PDbNGZIotZYPlvsEcggNUmZSXrq3BK7YB9tZYJyNM&itid=gfta
