Kisunla: A New Breakthrough for Alzheimer’s Disease
The FDA’s approval of Kisunla (donanemab-azbt) marks a significant advancement in the treatment of early-stage Alzheimer’s disease. Kisunla was developed by Eli Lilly, and this new drug targets amyloid plaques, which are abnormal protein accumulations in the brain. Amyloid plaques play a critical role in the progression of Alzheimer’s, offering a new avenue for managing this challenging condition.
Why Kisunla Matters
Kisunla is intended for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s. Early intervention is key, as the disease’s progression can be slowed before severe cognitive decline occurs. In clinical trials, Kisunla demonstrated a 35% reduction in cognitive decline over 18 months, allowing patients more time to manage their daily lives, maintain independence, and make important decisions about their future.
Safety and Adverse Effects
While Kisunla offers hope, it also comes with potential risks. The most serious of these is Amyloid-Related Imaging Abnormalities (ARIA), a condition characterized by brain swelling or microhemorrhages, observed in approximately 37% of patients. Though most cases of ARIA are mild and asymptomatic, they require regular MRI monitoring to manage the risks effectively.
How Kisunla Stands Out
Kisunla differentiates itself by offering a potentially shorter treatment duration. Unlike ongoing therapies like Leqembi (lecanemab-irmb), Kisunla treatment can be discontinued once amyloid plaques are sufficiently reduced, making it less burdensome for patients. However, the high cost, estimated at $26,500 per year, may limit access for some, raising important questions about affordability and insurance coverage.
The Impact
Kisunla’s approval represents a significant milestone in Alzheimer’s treatment. Although it is not a cure, it offers a meaningful option for slowing the progression of the disease, preserving cognitive function, and providing patients and their families with more quality time. This breakthrough brings hope to those affected by Alzheimer’s and underscores the ongoing need for innovation in this field.
References
- U.S. Food and Drug Administration. (2024). “FDA Approves New Treatment for Alzheimer’s Disease.” FDA Press Release. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-adults-alzheimers-disease
- Eli Lilly. (2024). “Lilly’s Kisunla Approved for Treatment of Early Alzheimer’s Disease.” Eli Lilly Press Release. https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early
- NBC News. (2024). “New Alzheimer’s Drug Kisunla Approved: What You Need to Know.” NBC News Article. https://www.nbcnews.com/health/health-news/fda-approves-eli-lillys-alzheimers-drug-slows-memory-decline-rcna158794
This Post Was Written By:
Nusrat Tabassum, PharmD Candidate 2025
