I received the following information on what from the Alzheimer association has been doing with the FDA to have medication approved
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
Chief Executive Officer
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