Alzheimer’s Foundation of America Statement on FDA Approving First New Alzheimer’s Medication in Nearly 20 Years
(June 7, 2021)—“The Alzheimer’s Foundation of America (AFA) always holds out hope that new medications, if found to be safe, effective, and approved by the FDA, will become available to help the millions of families and individuals affected by Alzheimer’s disease.
“Today’s accelerated approval of Aducanumab by the FDA, the first new Alzheimer’s drug on the market in nearly two decades, provides hope as another important step in the fight against Alzheimer’s disease. We are hopeful that it will improve the quality of life for individuals living with Alzheimer’s disease and their caregivers. Patient access and affordability to all of those in need is of significant importance.
“Under the accelerated approval provisions, which provide patients earlier access to the treatment, the FDA is requiring a new randomized, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw approval of the drug.
“Of course, the FDA’s actions do not signal the finish line in the fight against Alzheimer’s disease. It is essential for the federal government to continue building upon the actions it has taken to increase Alzheimer’s research funding, expand caregiver support services, and strengthen America’s ‘dementia infrastructure’ to enhance the diagnosis and treatment of Alzheimer’s disease.”