June 10, 2024 – On Monday, a panel of independent advisors to the Food and Drug Administration (FDA) endorsed Eli Lilly’s new Alzheimer’s drug, donanemab. This recommendation paves the way for donanemab to receive FDA approval in the U.S. later this year, marking a significant milestone in the battle against a disease that affects millions of individuals and their families worldwide.
The panel’s recommendation is based on compelling data from Eli Lilly’s comprehensive clinical trial program. In the pivotal Phase 3 study, donanemab demonstrated a significant slowing of cognitive and functional decline in patients with early symptomatic Alzheimer’s disease. The results showed that patients treated with donanemab experienced a substantial reduction in the progression of the disease compared to those receiving placebo.
“This brings new hope to patients and families affected by this life-changing condition,” said Dr. Joel Salinas, Isaac Health’s Chief Medical Officer. “This recommendation means that an external panel believes that donanemab has shown promising results in slowing cognitive decline in early symptomatic stages of Alzheimer’s. Now, the remaining step is for the FDA to give its review.”
Landmark Phase 3 Trial Results
The detailed findings from the Phase 3 trial were presented at the recent Alzheimer’s Association International Conference (AAIC). The study enrolled nearly 1,800 participants who were in the early stages of Alzheimer’s disease and exhibited the presence of amyloid plaques, a hallmark of the condition.
Key highlights from the trial include:
- Slowing of clinical decline: Donanemab slowed clinical decline by 35% compared to a placebo, a substantial reduction in the clinical progression of the disease.
- No clinical progression at one year: Nearly half (47%) of the participants receiving donanemab had no clinical progression at one year, compared to 29% on placebo.
- Improved daily living abilities: Donanemab treatment resulted in 40% less decline in participants’ ability to perform daily activities at 18 months.
- Amyloid plaque reduction: Donanemab effectively cleared amyloid plaques in the brain, with 68% of treated patients achieving amyloid negativity by 18 months.
- Lower risk of disease progression: Participants on donanemab had a 39% lower risk of progressing to the next stage of the disease compared to those on placebo.
A New Alzheimer’s Treatment Landscape
The recommendation of donanemab by a panel of FDA advisors is promising step for patients in the early stages of Alzheimer’s, where intervention can have the most impact. Individuals whose loved ones participated in the donanemab trial have described the possibility of slowing down cognitive decline as a “beacon of hope for [their] family.”
Isaac Health is committed to helping patients receive clinical guideline-recommended care for brain health conditions, including Alzheimer’s disease and related disorders. Our team of board-certified physicians are equipped to perform comprehensive evaluations, including cognitive assessments and lab tests, to ensure that patients receive the most appropriate care tailored to their condition. For more information on how Isaac Health can help you or a loved one, please visit our website at www.myisaachealth.com.
