FDA approves Donanemab, new Eli Lilly treatment for early Alzheimer’s disease

In today’s Health Alert, a new treatment that could slow Alzheimer’s disease has been approved by the Food and Drug Administration. The drug Donanemab, developed by Indianapolis-based company Eli Lilly, will be marketed under the brand name Kisunla.

Clinical trials found Kisunla produced meaningful results but also carried some serious safety risks.

Kisunla is a monoclonal antibody. It helps remove sticky amyloid plaque buildup in the brains of people with early Alzheimer’s disease. In late-stage clinical trials, the drug slowed cognitive decline in patients with this memory-loss disease. Those who took Kisunla had a 35% lower risk of their condition worsening over 18 months compared to those who received a placebo.

However, there were rare but serious risks. Three patients died after developing ARIA—short for amyloid-related imaging abnormalities – which can cause brain swelling and bleeding. These brain changes can be identified on MRI scans. Because of this, the drug company added an additional MRI scan. If ARIA was detected, treatment was paused to allow the brain to resolve the issue since it’s usually temporary. Overall, during the trial, 2% of patients who took Kisunla died, compared to 1.7% in the group that didn’t.

Both Kisunla and Leqembi slow down dementia by targeting amyloid plaque buildup in the brain. They are lab-made antibodies given intravenously. In trials, Leqembi also caused ARIA, but less often than Kisunla. Leqembi has also been linked to patient deaths.

Now, there are two main differences between the drugs. One is how often they’re given. Kisunla is administered once a month, while Leqembi is twice a month. Secondly, Kisunla can be stopped once the plague is barely detectable in the brain. In the trial, 47% of participants stopped using the drug after a year, and 69 percent stopped after 18 months. Amazingly, their mental decline continued to slow down even after they stopped taking the drug. This is a major plus because Kisunla is not cheap. Predicted costs are $695 per vial before insurance. That adds up to $12,522 for six months or about $32,000 a year.

It’s great that there is another treatment option for Alzheimer’s disease. This memory-robbing chronic brain condition affects about 6.7 million Americans, with numbers predicted to rise to 14 million by 2060. And while Kisunla is not a cure and works best in the early stage of the disease, it could potentially help people with Alzheimer’s live longer and more fulfilling lives.

This Week on the Dr. Nandi Show:

Thyroid problems are often overlooked or misdiagnosed. Join Dr. Partha Nandi and his expert guests, who unlock the mystery surrounding this very important gland. Dr. Amy Myers tells her own personal story about having a thyroid disorder and how she is helping other women with similar issues. Plus, author Rock Robbins reveals the harrowing story of his wife’s journey with thyroid disease and how it affected their marriage. Tune in this Saturday, July 6th, at 12:00 PM.