President & CEO Update
Alzheimer's Association
This message is sent to all Alzheimer's Association and Alzheimer's
Impact Movement board members, all Alzheimer's Association staff, and
volunteers and supporters of AIM and the Alzheimer's Association.
This morning, Biogen announced that the FDA has extended the review
period for aducanamab by three months, to June 7, 2021. The FDA
requested additional data and analyses for its review of the potential
treatment for Alzheimer's. The request for the additional data
and analyses is considered a Major Amendment to the FDA application,
which drives the extended time for review.
As a science-based patient advocacy organization, we are encouraged
and appreciate the thoughtful and rigorous review of scientific data
and analysis by the FDA.
We believe the publicly released scientific data, the crushing
realities faced by individuals and families living with
Alzheimer's, and no approved treatment for the underlying
disease, support FDA approval of aducanumab, accompanied by a Phase 4
post marketing surveillance study.
If approved, aducanumab would be the first available treatment to
potentially change the progression of Alzheimer's, not just the
symptoms, for millions of people facing the disease today.
We will continue to advocate, driven by science, on behalf of our
constituents. I will continue to share important developments as the
FDA pursues their review process. And, I will notify you when they
announce a final decision. Of course, no matter the outcome in this
case, we remain relentless in our efforts to realize our vision of a
world without Alzheimer's. Thank you for everything you do to
make that possible.
Harry Johns Signature
Harry Johns
Chief Executive Officer
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Alzheimer's Association
Alzheimer's Association
225 N. Michigan Ave., FL 17, Chicago, IL
60601
800.272.3900 | alz.org
tel:800.272.3900
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