Alzheimer's Association Applauds FDA Panel's Unanimous Vote on Donanemab for Early Alzheimer's

CHICAGO, June 10, 2024 — The Alzheimer's Association has expressed enthusiasm following the U.S. Food and Drug Administration (FDA) advisory committee's unanimous decision affirming the effectiveness of donanemab, produced by Eli Lilly, for early Alzheimer's disease treatment. This encompasses mild cognitive impairment and mild Alzheimer's dementia, with the committee concluding that the benefits of the treatment surpass its risks.

Should the FDA grant approval, donanemab will become the second Alzheimer's treatment to receive traditional approval for altering the disease's underlying progression. It will be the third FDA-approved drug in this class overall.

"Having more approved treatments for Alzheimer's represents significant progress for those eligible for these drugs," stated Joanne Pike, DrPH, president and CEO of the Alzheimer's Association. "We need a diverse range of treatments targeting various aspects of Alzheimer's, with enhanced efficacy and safety. This will pave the way for combination therapies addressing the disease's complexity. Our vision is a life rich and robust, free from memory loss, confusion, or cognitive decline."

The Alzheimer's Association, along with its Early Stage Advisory Group members, has actively advocated for the FDA advisory committee to recommend traditional approval of donanemab. The next phase in the regulatory process is a comprehensive review by the FDA.

The Alzheimer's Association is dedicated to collaborating with healthcare systems and providers to ensure sufficient resources and infrastructure are available to meet patient needs. The Association strongly advocates for prescribers to join the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET), which is collecting real-world data on patient responses to new FDA-approved Alzheimer's therapies from diverse backgrounds and communities.

"We anticipate more treatment options and innovative therapies that address other dimensions of Alzheimer's, including lifestyle and behavioral interventions," remarked Maria C. Carrillo, Ph.D., chief science officer and medical affairs lead at the Alzheimer's Association. "We expect to hear results from various Alzheimer's and dementia treatments and risk reduction strategies at the Alzheimer's Association International Conference (AAIC) from July 28 to August 1 in Philadelphia."

The Alzheimer's Association is a leading organization working towards ending Alzheimer's and all other dementias by accelerating global research, driving risk reduction, promoting early detection, and enhancing quality care and support. Their vision is a world without Alzheimer's and other dementias.