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

Health Care Professionals

As a physician, you may have questions about aducanumab. We will try to answer them below.

  1. When could aducanumab launch in the U.S. and other markets?
    1. We are working with a sense of urgency to bring this potential treatment to patients as soon as possible.
    2. We are working to submit a drug application to the FDA in early 2020 and we will continue dialogue with regulatory authorities in international markets including Europe and Japan.
  2. What does this mean for the patients previously enrolled in the discontinued trials?
    1. First of all, we want to thank you for your participation in this research program. We intend to start a re-dosing study as soon as possible and we are seeking guidance from the regulatory authorities and institutional review boards in order to do so.
    2. We aim to offer access to aducanumab to eligible patients previously enrolled in aducanumab clinical trials.
  3. 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
  4. What should I say to my patients?
    1. We are optimistic about the results we have seen with aducanumab as we believe they have potential for people with mild cognitive impairment due to Alzheimer’s disease or mild dementia due to Alzheimer’s disease. However, aducanumab is still an investigational drug and not yet available outside of the clinical studies.
    2. We are working to submit a drug application to the FDA in early 2020 and we will continue dialogue with regulatory authorities in international markets including Europe and Japan.