תרופה חדשה לחולי דמנציה ואלצהיימר: התרופה בדרך לאישור Aducanumab for Alzheimer’s

Biogen Will Take Alzheimer's Therapy to FDA, Reviving HopeBiogen Inc. will ask U.S. drug regulators to approve the company’s experimental Alzheimer’s therapy, reviving the nearly abandoned treatment after a new analysis of data from two failed clinical trials showed promising 


 

https://www.cnbc.com/video/2019/10/22/biogen-fda-approval-alzheimers-drug-aducanumab.html
[size=30]Biogen to seek FDA approval for Alzheimer's drug Aducanumab[/size]

[size=40]Biogen’s good news on aducanumab could ‘open the floodgates’ for Alzheimer’s drugs[/size]
https://www.statnews.com/2019/10/23/aducanumab-news-open-floodgates-alzheimers-drugs/



[size=33][size=33]That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet[/size][/size]
After declaring aducanumab a failure, the manufacturer now says the drug may help slow cognitive decline in certain patients. Some experts are skeptical.
https://www.nytimes.com/2019/10/22/health/alzheimers-dementia-aducanumab.html



A review of brain scans of patients with dementia at the Banner Alzheimer’s Institute in Phoenix. Biogen, a drug company, said on Tuesday that it would seek approval for a drug to treat early Alzheimer’s disease.CreditMatt York/Associated Press









[size=40]BIOGEN PLANS REGULATORY FILING FOR ADUCANUMAB IN ALZHEIMER’S DISEASE BASED ON NEW ANALYSIS OF LARGER DATASET FROM PHASE 3 STUDIES[/size]



https://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease

[size=42]Trick or Treat?’ Analysts react to Biogen’s aducanumab surprise[/size]


https://www.fiercebiotech.com/biotech/trick-or-treat-analysts-react-to-biogen-s-aducanumab-surprise

[size=46]Aducanumab[/size]

[size=46]Aducanumab
HOME » ADUCANUMAB
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Aducanumab (BIIB037) was being developed by Biogen as a possible therapy for Alzheimer’s disease. However, in March 2019, an independent data monitoring committee determined there was insufficient evidence supporting the efficiency of aducanumab in treating the disease. As a result, all clinical trials testing the treatment have been halted.
The treatment was originally developed by Neurimmune, which, after entering a partnership with Biogen in 2007, had granted Biogen the license to further develop and commercialize aducanumab. Biogen had been collaborating with Eisai to advance the clinical studies of aducanumab since October 2017
https://alzheimersnewstoday.com/aducanumab/

[size=34]Neurimmune Welcomes Biogen's News on Clinical Benefit of Aducanumab

http://www.neurimmune.com/newsarticle/22102019-neurimmune-welcomes-biogens-news-on-clinical-benefit-of-aducanumab.html




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https://www.medpagetoday.com/neurology/alzheimersdisease/82865
[size=32]Biogen Reverses Take on Aducanumab Trial Data[/size]

— Says reanalysis shows anti-amyloid drug is a winner for Alzheimer's disease

Aducanumab

Aducanumab is a human monoclonal antibody that has been studied for the treatment of Alzheimer's disease (AD).^[1] It was developed by Biogen Inc., which licensed the drug candidate from Neurimmune, its discoverer.^[2] The antibody targets aggregated forms of β-amyloid found in the brains of people with Alzheimer’s disease, in the hopes of reducing its buildup.^[3] Biogen halted development of the drug in March 2019 after preliminary data from two phase III trials suggested it would not meet the primary endpoint.^[4][5][6] On 22 October 2019 Biogen announced that it would be re-starting the FDA approval process for aducanumab stating that new analysis of a larger dataset showed that the drug reduced clinical decline in patients with early Alzheimer's disease when given at higher doses.^[7] The reanalysis of the data from the discontinued trial concluded that patients receiving a high dose had a 23% reduction in their rate of decline.^[8][9]

Research

Interim results from the second Phase 1 study of the drug wer

[list=references]
[*] Cynthia Fox for Drug Discovery and Development (April 28, 2015). "The Story of Biogen's Alzheimer's Drug, Aducanumab Archived 2015-07-01 at the Wayback Machine".

[*]^ Rebecca Zacks for Xconomy (November 20, 2007). "Biogen Inks $380 Million Deal with Swiss Company".

[*]^ Toyn, Jeremy (2015). "What lessons can be learned from failed Alzheimer's disease trials?". Expert Rev. Clin. Pharmacol. 8 (3): 267–269. doi:10.1586/17512433.2015.1034690. PMID 25860157.

[*]^ "Biogen Halts Promising Alzheimer's Drug Trials Due to Disappointing Results". Time. Retrieved 2019-03-21.

[*]^ https://www.cnbc.com/2019/03/21/biogen-shares-plunge-more-than-25percent-after-ending-trial-for-alzheimers-drug-aducanumab.html

[*]^ https://www.bostonglobe.com/business/2019/03/21/biogen-shares-plunge-after-alzheimer-drug-setback/0MzLJWlEgmo5nHSKWl8esO/story.html?p1=Article_Recommended_ReadMore_Pos1

[*]^ CNN, Jacqueline Howard and Jamie Gumbrecht. "Drugmaker to seek approval for Alzheimer's treatment". CNN. Retrieved 2019-10-23.

[*]^ Herper, Matthew (2019-10-22). "In shocking reversal, Biogen to submit Alzheimer's drug for approval". STAT. Retrieved 2019-10-22.

[*]^ "Biogen Plans Regulatory Filing for Aducanumab in Alzheimer's Disease Based on New Analysis of Larger Dataset from Phase 3 Studies". Biogen. Retrieved 2019-10-22.

[*]^ Matthew Herper for Forbes. March 20, 2015 Biogen Drug Could Inspire New Hope For Alzheimer's Treatments

[*]^ Jump up to:^a b Sevigny J.; Chiao P.; Bussière T.; Weinreb P.H.; Williams L.; Maier M.; Dunstan R.; Salloway S.; Chen T.; Ling Y.; O'Gorman J.; Qian F.; Arastu M.; Li M.; Chollate S.; Brennan M.S.; Quintero-Monzon O.; Scannevin R.H.; Arnold H.M.; Engber T.; Rhodes K.; Ferrero J.; Hang Y.; Mikulskis A.; Grimm J.; Hock C.; Nitsch R.M.; Sandrock A. (1 September 2016). "The antibody aducanumab reduces Aβ plaques in Alzheimer's disease". Nature. 537(7618): 50–56. doi:10.1038/nature19323. PMID 27582220.

[*]^ Li, Yun (21 March 2019). "Biogen shares plunge nearly 30% after ending trial for Alzheimer's drug Aducanumab". CNBC.

[*]^ "First drug to slow Alzheimer's may be available soon". BBC News. 22 October 2019. Retrieved 22 October 2019.

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e reported in March 2015.^[1][10]

A phase 1b study was published in August 2016, based on one year of "monthly intravenous infusions" of aducanumab, with brain scans to measure amyloid plaques.^[11] Phase 3 clinical trials were ongoing in September 2016,^[11] but were canceled in March 2019 after "an independent group's analysis show[ed] that the trials were unlikely to 'meet their primary endpoint.'"^[12]

Despite this, in October 2019 the company announced their intention to seek regulatory approval, following a reanalysis of the data

https://www.nature.com/articles/nature19323

Article | Published: 31 August 2016
[size=39]The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease[/size]

https://www.en24.news/2019/10/revolutionary-drug-for-alzheimers-disease-resurfaces.html
[size=41]revolutionary drug for Alzheimer's disease resurfaces[/size]
[size=41]In March 2019, the biopharmaceutical company Biogen stopped the clinical trials for a new molecule used in the treatment of Alzheimer's disease: aducanumab. This drug, described as revolutionary at the time of its presentation, directly targets the amyloid deposits responsible – in part – for the disease. It represented a real hope for the millions of patients around the world, and stopping its development, for obvious reasons of inefficiency, was a shock for all patients. However, by re-analyzing the data from the two clinical trials, Biogen's researchers found that aducanumab slowed the progression of the disease at a high dose. A hopeful turnaround that should bring the drug back to trial.[/size]
[size=41][/size]

[size=32]New Alzheimer’s drug clears abnormal protein clogs in small, promising trial[/size]
https://www.pbs.org/newshour/science/new-alzheimers-drug-clears-amyloid-protein-clogs-small-promising-trial


[size=30]Aducanumab is an antibody, a natural substance the body produces to fight disease.[/size]

http://www.brainimmune.com/aducanumab-shows-promise-impressive-effects-reducing-alzheimers-amyloid-%CE%B2-plaques/

Aducanumab Shows Promise and Impressive Effects in Reducing Alzheimer’s Amyloid-β Plaques

2016




[size=33][size=33]That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet[/size][/size]
After declaring aducanumab a failure, the manufacturer now says the drug may help slow cognitive decline in certain patients. Some experts are skeptical.
https://www.nytimes.com/2019/10/22/health/alzheimers-dementia-aducanumab.html

https://www.fastcompany.com/90420598/5-things-to-know-about-aducanumab-biogens-resurrected-alzheimers-drug+

[size=44]5 things to know about Aducanumab, Biogen’s resurrected Alzheimer’s drug[/size]

[size=39]The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease[/size]
https://www.nature.com/articles/nature19323?platform=hootsuite

[size=35]We're on the brink of the first new treatment for Alzheimer's in almost two decades. Here's what you need to know.[/size]
https://www.businessinsider.com/biogen-plans-to-file-alzheimers-drug-aducanumab-for-approval-2019-10

[size=39]Biogen Alzheimer’s Drug Could Alter ‘Concept of Senior Living’[/size]
https://moneyandmarkets.com/biogen-alzheimers-drug-aducanumab/

[size=45]Explained: Can ‘aducanumab’ treat Alzheimer’s disease? [/size]

A new analysis called “EMERGE” led by Biogen in consultation with the FDA shows that administration of the drug may be able to reduce clinical decline in patients in the early stages of Alzheimer’s disease.

https://moneyandmarkets.com/biogen-alzheimers-drug-aducanumab/


https://news.joindementiaresearch.nihr.ac.uk/aducanumab-positive-results-alzheimer/
Positive results from Alzheimer’s drug in Phase 1 clinical trial extension
The pharmaceutical company Biogen has today announced the results of an extended phase 1b clinical trial of the potential Alzheimer’s disease drug, aducanumab. Results from the extended early-stage trial were announced today at Clinical Trials in Alzheimer’s Disease (CTAD) conference in Boston.
https://news.joindementiaresearch.nihr.ac.uk/