Eisai and Biogen are applying to the FDA for priority review of the treatment of Alzheimer's disease.

Biogen and Eisai, the pharmaceutical companies, said recently that the FDA had accepted a request for priority review of aducanumab's treatment of Alzheimer's disease and had set a target date of March 7 next year.
the two companies noted that the agency also intends to hold an advisory board meeting to discuss the proposal, adding that regulators plan to take action as soon as possible.
Aducanumab (BIIB037) is a research human monoclonal antibody that has been studied for the treatment of early-stage Alzheimer's disease.
biogen acquired aducanumab from Neurimmune under a co-development and licensing agreement.
since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab worldwide.
EMERGE and ENGAGE are phase III multi-center, randomized, double-blind, placebo-controlled, parallel group studies designed to assess the efficacy and safety of aducanumab.
the main endpoint of the study was to assess the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment compared to placebos, as measured by changes in CDR-SB scores.
secondary endpoint was to assess the effect of aducanumab versus placebo on changes in MMSE, ADAS-Cog 13 and ADCS-ADL-MCI scores.
Alzheimer's disease, commonly known as early-onset dementia and Alzheimer's disease, is a slow-moving, worsening neurodegenerative disease that accounts for six to seven out of every five causes of dementia.
The most common early symptoms are loss of short-term memory (difficult to remember recent events), and as the disease progresses, symptoms may develop gradually, including language disorders, disorientation (including easy getting lost), emotional instability, loss of motivation, inability to take care of themsself, and many behavioral problems.
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