CAMBRIDGE -
The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on
'The
'Reducing clinical decline and maintaining the ability to live an independent life for as long as possible are things that people living with Alzheimer's disease and their families value in a potential treatment,' said Dr.
Biogen did not use its Priority Review voucher for the aducanumab BLA. The FDA also stated that it is currently planning to hold an Advisory Committee meeting for this application on a yet-to-be-determined date.
'Today, I am heartened by what this progress may mean for people living with Alzheimer's disease and their families,' said Dr.
About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer's disease. Based on clinical data from patients with Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients' ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer's.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since
EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).
About Alzheimer's Disease
Alzheimer's disease is a progressive neurological condition that impairs thinking, memory and independence, leading to premature death. The disease currently cannot be stopped, delayed or prevented and is a growing global health crisis, affecting those living with the disease and their families. According to the
Alzheimer's disease is characterized by changes in the brain, including the abnormal accumulation of toxic amyloid beta plaque, which begins approximately 20 years before patients exhibit symptoms of the disease. Mild cognitive impairment due to Alzheimer's disease is one of the earliest stages of the disease when symptoms start to be more visible and can be detected and diagnosed. Current research efforts are focused on catching and treating patients as early as possible for the best chance of slowing or stopping the progression of Alzheimer's disease.
About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by
About
Leveraging the experience gained from the development and marketing a treatment for Alzheimer's disease,
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about potential regulatory discussions, submissions and approvals and the timing thereof; the potential clinical effects of aducanumab; the potential benefits, safety and efficacy of aducanumab; the identification and treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including aducanumab; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; uncertainty of success in the development and potential commercialization of aducanumab; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab and other unexpected difficulties or hurdles; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the
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