FDA Hears Crushing Impact of Alzheimer's
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.
Last week, the Food and Drug Administration (FDA) heard the
heart-wrenching personal stories of individuals whose lives have been
devastated by Alzheimer's disease.
The Alzheimer's Association worked directly with the FDA to
arrange this session as part of our advocacy for new treatments. We
were deeply concerned that the voices of those diagnosed with
Alzheimer's and their caregivers had not truly been heard during
a recent advisory committee meeting on aducanumab, an
Alzheimer's treatment developed by Biogen, now under review by
the FDA.
On behalf of the millions of Americans facing Alzheimer's every
day, the speakers candidly and powerfully used their voices to
communicate the immediate need for treatment to FDA leaders. We are
deeply grateful to each of the speakers, who so openly, and often
emotionally, talked about the crushing impact of Alzheimer's on
their own lives and the lives of their loved ones.
Hearing the staggering realities of living with Alzheimer's,
with no treatment available for its underlying cause, the FDA
participants were certainly engaged and expressed their appreciation
for the speakers' openness and honesty.
I told the FDA leaders that the Alzheimer's Association, as a
science-driven organization, continues to believe what we have told
them previously, that aducanamab should be approved.
If approved, it would be the first treatment to potentially change the
progression of Alzheimer's, not just the symptoms. We believe
the accumulated science, the publicly released data on aducanumab and
the absence of any other treatment addressing the cause of the disease
justifies FDA approval, accompanied by a Phase 4 post marketing
surveillance study.
Be assured, we will keep working on this on behalf of the millions
affected by Alzheimer's until a decision is made. And then,
whatever the decision, we'll continue to work relentlessly until
we realize our vision of a world without Alzheimer's.
I will share more news with you when the FDA makes its final decision.
As always, thank you for everything you do to advance our mission to
make a difference for others - today and tomorrow.
Harry Johns Signature
Harry Johns
Chief Executive Officer
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