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Aducanumab is an investigational drug and is not approved for use in the U.S. or any other country.

About aducanumab

Aducanumab is an investigational drug being evaluated for the treatment of early Alzheimer’s disease. Aducanumab is not approved for use in the U.S. or any other country.

Aducanumab is a human monoclonal antibody that targets amyloid beta, a protein that abnormally accumulates in the brains of people with Alzheimer’s disease.

EMERGE and ENGAGE were clinical research studies evaluating the efficacy and safety of aducanumab in people experiencing symptoms of early Alzheimer’s disease, such as problems with memory or thinking clearly.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.

  1. What is aducanumab?
    1. Aducanumab is an investigational drug being evaluated for the treatment of early Alzheimer’s disease.
    2. It is a human monoclonal antibody that targets amyloid beta, a protein that abnormally accumulates in the brains of people with Alzheimer’s disease.
  2. What are EMERGE and ENGAGE?
    1. EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of two dosing regimens of aducanumab.
  3. What did Biogen announce?
    1. Biogen plans to file for market approval for aducanumab in the U.S. based on a new analysis of a larger dataset and discussions with the U.S. Food and Drug Administration (FDA).
      1. The Phase 3 EMERGE study met its primary endpoint showing a significant reduction in clinical decline. We believe that results from a subset of patients in the ENGAGE study who received sufficient exposure to high dose aducanumab support the findings in the EMERGE study.
    2. This new analysis showed that compared to placebo, greater exposure to high dose aducanumab resulted in significant benefits on measures of cognition and function such as memory, orientation and language, as well as activities of daily living such as conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.
    3. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes compared to placebo.
  4. What is a futility analysis?
    1. A futility analysis for a clinical research study is an analysis before the end of a trial with the purpose to evaluate if the study is likely to meet its primary endpoint (e.g., if the investigational drug is effective).
    2. Futility analyses are typically conducted in large or lengthy studies to ensure that patients are not exposed to a drug that is either not likely to work and/or potentially has serious side effects.
  5. What changed since the discontinuation of the phase 3 clinical studies of aducanumab in March 2019?
    1. We announced the decision to discontinue the global Phase 3 EMERGE and ENGAGE clinical studies of aducanumab as well as PRIME and EVOLVE, based on the results of a pre-planned futility analysis in March 2019.
    2. The futility analysis predicted that both studies were unlikely to meet the primary endpoint upon completion. Following the discontinuation, additional data from these studies became available and the new analysis of this larger dataset showed the futility analysis did not accurately predict the final outcome of these studies.
    3. We now know that the EMERGE study met its primary endpoint showing statistically significant reduction in clinical decline compared to placebo. We believe that results from a subset of patients in the ENGAGE study who received sufficient exposure to high dose aducanumab support the findings in the EMERGE study.