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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 in October 2019?
    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, as per the pre-specified statistical analysis plan, showing a statistically significant reduction in clinical decline compared to placebo. Biogen also showed results from a subset of patients in the ENGAGE study, who were randomized to the 10 mg/kg high dose of aducanumab, that support the findings from EMERGE.
    2. Patients from the high dose group in EMERGE experienced 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.
  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 studies.
    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. Conversations with regulatory authorities in international markets for potential marketing authorization submissions continue to progress.
    2. We will be working with a sense of urgency with all key stakeholders toward a goal of providing access to aducanumab.
  7. What did Biogen present at the 12th Clinical Trials on Alzheimer’s Disease (CTAD)?
    1. On December 5, 2019, Biogen presented additional details from EMERGE and ENGAGE, two global Phase 3 studies for aducanumab at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Congress in San Diego, CA. During this presentation, Biogen shared the topline data on the primary and secondary clinical endpoints based on the pre-specified statistical analysis plan, as well as data from disease biomarker sub-studies, including amyloid PET, tau PET and tau CSF biomarkers. Furthermore, we presented patient demographic characteristics and safety results from each study. LEARN MORE