CHICAGO, June 10, 2024 — The Alzheimer’s Association welcomes today’s U.S. Food and Drug Administration (FDA) advisory committee’s unanimous finding that donanemab (Eli Lilly) is effective for the treatment of early Alzheimer’s disease, which includes mild cognitive impairment and mild Alzheimer’s dementia, and that the treatment’s benefits outweigh the risks.
If approval is granted by the FDA, donanemab will be the second traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease, and the third FDA approval overall in this class of treatments.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO.
“Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety. This will lead to possibilities for combination therapies that address the complexity of the disease. A rich and robust life without the threat of memory loss, confusion or cognitive decline: this is what we envision,” Pike said.
The Alzheimer’s Association and members of the Association’s Early Stage Advisory Group each submitted comments urging the Advisory Committee to recommend traditional approval of donanemab. The next regulatory step toward approval of the treatment is FDA review.
The Alzheimer’s Association is committed to working with health systems and providers to ensure they have the resources and infrastructure to meet the needs of their patients. The Association strongly encourages prescribers to participate in the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET), which is gathering real world data on how people from all backgrounds and communities respond to novel FDA-approved Alzheimer’s therapies.
“We look forward to more treatment options, and novel therapies that target other aspects of the disease, including lifestyle and behavioral-based interventions,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead. “We will hear results from a variety of Alzheimer’s and dementia treatments and risk reduction strategies at the Alzheimer’s Association International Conference (AAIC), July 28 to Aug. 1 in Philadelphia.”
