The Food and Drug Administration (FDA) Advisory Committee recommended that the new drug, aducanumab, not be approved by the FDA to treat Alzheimer’s disease on November 6, 2020. All are disappointed by this news, and the Alzheimer’s Association continues to advocate for its approval.
As stated by the Alzheimer’s Association on November 6:
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.
We will continue to keep you updated on the development of new dementia treatments.