Show threadMatteo Cesari Jun 12, 2024

@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...

https://pubmed.ncbi.nlm.nih.gov/34331706/

"Real world" eligibility for aducanumab - PubMed

"Real world" eligibility for aducanumab

PubMed
Show threadCarolyn Barber, MDApr 6, 2024

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/

Amylyx to pull ALS drug from market, cut 70% of staff

Amylyx Pharmaceuticals will take its ALS drug off the market in the U.S. and Canada, ending a multi-year saga for patients with the disease.

STAT
Bruce MirkenFeb 4, 2024
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
Biogen to stop selling Alzheimer's drug Aduhelm

Biogen will stop developing its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster before stumbling soon after its launch a couple years ago.

NBC News
LupposofiFeb 2, 2024

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

#alzheimers #aducanumab #aduhelm #biogen

Adieu to Aduhelm: Biogen Stops Marketing Antibody | ALZFORUM

cafepharmaJan 31, 2024
Novo Nordisk doubles stock of Wegovy starter—GSK sees strong growth as Haleon split and vaccine drive pays off — Biogen abandons Aduhelm efforts--http://bit.ly/w28kSd #novonordisk #wegovy #gsk #earnings #haleon #biogen #alzheimers #aduhelm #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Show threadKarl HerrupJul 6, 2023

@robertroybritt

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.

Benjamin Carr, Ph.D. 👨🏻‍💻🧬Apr 20, 2023
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
Four senior FDA leaders forged close ties with Biogen ahead of Aduhelm's approval. Now they've all left ...

Two years after the FDA's controversial approval of Biogen's Alzheimer's drug Aduhelm, four of the top agency officials who came under scrutiny for their close relationship with the drugmaker during the approval process have left the agency. Three of those four senior officials, who managed and worked closely with the

Endpoints News
Corinna LoeckenhoffJan 3, 2023
Congressional inquiry raises serious questions about irregularities behind #aduhelm approval. #aging #alzheimers https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html?action=click&module=Well&pgtype=Homepage&section=Health
Congressional Investigation into Alzheimer’s Drug Aduhelm Faults the F.D.A. and Biogen

The report said the F.D.A.’s approval process for Aduhelm was “rife with irregularities” and criticized Biogen for setting an “unjustifiably high price.”

Thiago CarvalhoJan 2, 2023

"The 18-month investigation, initiated by two congressional committees after the F.D.A. approved the drug, also strongly criticized Biogen, Aduhelm’s manufacturer. Internal documents showed the company set “an unjustifiably high price” of $56,000 a year for Aduhelm because it wanted a history-making “blockbuster” to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found."

#Aduhelm #MonoclonalAntibody #Alzheimer #AlzheimersDisease #Aducanumab

https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html?action=click&module=Well&pgtype=Homepage&section=Health

Congressional Investigation into Alzheimer’s Drug Aduhelm Faults the F.D.A. and Biogen

The report said the F.D.A.’s approval process for Aduhelm was “rife with irregularities” and criticized Biogen for setting an “unjustifiably high price.”

Donna YoungDec 29, 2022
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
Maloney and Pallone Release Staff Report on Review, Approval, and Pricing of Biogen’s Alzheimer’s Drug Aduhelm

Chairs Pallone and Maloney released a report on the review, approval, and pricing of Alzheimer's drug, Aduhelm

Democrats, Energy and Commerce Committee