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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 this announcement. We will try to answer them below.

  1. When should others in the Alzheimer’s and medical community expect to see more detailed data?
    1. We plan to present further detail at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego in December 2019.
  2. 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.
  3. 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 the aducanumab Phase 3 studies, the long-term extension study for the Phase 1b PRIME study and the EVOLVE safety study.
  4. When is Biogen presenting 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.
  5. 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 study.
    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.