Aducanumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | beta amyloid |
| Clinical data | |
| Other names | BIIB037 |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| ChemSpider |
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| KEGG | |
| Chemical and physical data | |
| Formula | C6472H10028N1740O2014S46 |
| Molar mass | 145909 g·mol−1 |
Aducanumab is a human monoclonal antibody that has been studied for the treatment of Alzheimer's disease (AD).[2] It was developed by Biogen Inc., which licensed the drug candidate from Neurimmune, its discoverer.[3] 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.[4] 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.[5][6][7] 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.[8] 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.[9][10]
Research
Interim results from the second Phase 1 study of the drug were reported in March 2015.[2][11]
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.[12] Phase 3 clinical trials were ongoing in September 2016,[12] but were canceled in March 2019 after "an independent group's analysis show[ed] that the trials were unlikely to 'meet their primary endpoint.'"[13]
Despite this, in October 2019 the company announced their intention to seek regulatory approval, following a reanalysis of the data.[14][15]
References
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
- ^ a b 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.
{{cite web}}:|last=has generic name (help) - ^ Herper, Matthew (2019-10-22). "In shocking reversal, Biogen to submit Alzheimer's drug for approval". STAT. Retrieved 2019-10-22.
{{cite web}}: CS1 maint: url-status (link) - ^ "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
- ^ 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.
- ^ "Drug 'could be biggest Alzheimer's development'". BBC News. 2019-10-26. Retrieved 2019-10-26.
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