Skip to content

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

FAQ

We understand you have many questions about the announcement. We will try to answer them below.

  1. 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.
  2. What does this mean for someone with early Alzheimer’s disease who was not in any of the aducanumab studies?
    1. We are optimistic about the results we have seen with aducanumab as we believe they have potential for people with early Alzheimer’s disease. However, aducanumab is still an investigational drug and not yet available outside of the clinical study.
    2. We are also working to submit a drug application to the FDA, which we plan to do in early 2020, and we will continue dialogue with regulatory authorities in international markets, including Europe and Japan, for other potential submissions.
  3. When does Biogen expect to file for regulatory approval with the FDA?
    1. We are also working to submit a drug application to the FDA, which we plan to do in early 2020, and we will continue dialogue with regulatory authorities in international markets, including Europe and Japan, for other potential submissions.
  4. How long would it take to file and get approval?
    1. We are working with a sense of urgency to bring this potential treatment to patients as soon as possible.
    2. We are also working to submit a drug application to the FDA, which we plan to do in early 2020, and we will continue dialogue with regulatory authorities in international markets, including Europe and Japan, for other potential submissions.
  5. When would aducanumab launch in the U.S. and other markets, and be available to me?
    1. We are working with a sense of urgency to bring this potential treatment to patients as soon as possible.
    2. We are also working to submit a drug application to the FDA, which we plan to do in early 2020, and we will continue dialogue with regulatory authorities in international markets, including Europe and Japan, for other potential submissions.
  6. I’m a patient living outside the United States. How will I gain access to aducanumab?
    1. We are planning to engage with regulatory authorities around the world for potential marketing authorization submissions. We will be working with a sense of urgency with all key stakeholders toward a goal of providing access to aducanumab.
  7. When will you present the data?
    1. We plan to present further detail at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego in December 2019.