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.
I am disappointed to report that a Food and Drug Administration (FDA) Advisory Committee
recommended today that a new drug not be approved by the FDA to treat Alzheimer’s. This is not the end of the road. It is one step in the FDA review process.
The Alzheimer’s Association will continue to advocate for the FDA to approve aducanamab.
In her testimony before the committee, Alzheimer’s Association Chief Strategy Officer, Dr. Joanne Pike, outlined the need to offer relief to the millions of Americans, those with the disease and their caregivers, who face the crushing realities of Alzheimer's.
Though the treatment would potentially delay decline, not stop onset or progression, given the devastating toll of Alzheimer’s, we believe the publicly-released data on aducanumab justify FDA approval, accompanied by a Phase 4 post marketing surveillance study.
The alternative — an additional Phase 3 trial — would deny access up to four years. A four-year delay is too long for too many — those who have the disease and their caregivers.
We have never before been this close to approval of a drug for Alzheimer’s that could change the progression of the disease, not just the symptoms.
Again, the Alzheimer’s Association will continue to advocate for approval.
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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