Potential Breakthrough For Early Developments Of Alzheimer's Disease

The U.S. Food and Drug Administration (FDA) Advisory Committee unanimous finding that Donanemab (Eli Lilly) is effective for the treatment of early Alzheimer’s Disease.

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.

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.

Alzheimer’s Association spokespeople are available to discuss: The impact of this decision on treatment, care and living with Alzheimer’s; Alzheimer’s Association efforts to ensure access to the drug; The status and future of Alzheimer’s research; What it is like to live with Alzheimer’s or another dementia, and to provide care.

Contact Nancy Rainwater, [email protected] or Lionell Martin, [email protected] to set up an interview.

Alzheimer’s is a progressive, degenerative and fatal brain disease. It is the most common cause of dementia. For Alzheimer’s Disease Facts and Figures, an annual report by the Alzheimer’s Association, visit alz.org/facts.

Joanne Pike, Dr.PH Alzheimer’s Association president and CEO explains, a future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening.

Now more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety, are needed. 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 is envisioned.

Maria C. Carrillo, Ph.D., Alzheimer’s Association, chief science officer explains, they look forward to more treatment options, and novel therapies that target other aspects of the disease, including lifestyle and behavioral-based interventions.

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.