FDA Approves Donanemab for Early Symptomatic Alzheimer’s Disease

The US Food and Drug Administration (FDA) has approved donanemab, a monoclonal antibody, for the treatment of early symptomatic Alzheimer’s disease. This drug, developed by Eli Lilly, is designed to slow the progression of the disease by targeting and helping the body remove amyloid plaque buildup in the brain, a hallmark of Alzheimer’s.

Donanemab, which will be sold under the name Kisunla, marks a significant advancement in Alzheimer’s treatment. Priced at $695 per vial before insurance, the cost of a six-month course of treatment is approximately $12,522, or around $32,000 annually, depending on the treatment duration.

Clinical Trial Results

While donanemab is not a cure for Alzheimer’s, clinical trials have shown that it can significantly slow the disease’s progression. Patients treated with donanemab exhibited about a 35% lower risk of disease progression over a year and a half compared to those given a placebo. This slowdown allows patients to maintain their independence and participate in daily activities for a longer period.

Despite its benefits, the clinical trials did report some serious adverse events, though these were rare. About 2% of patients experienced adverse events, including a slightly higher mortality rate of 2% compared to 1.7% in the placebo group. Three patients died after developing amyloid-related imaging abnormalities (ARIA), a condition involving micro-hemorrhages. To mitigate this risk, an additional MRI was included in the trial protocol to detect asymptomatic ARIA before administering the second dose.

Comparison with Other Treatments

Kisunla is not the first monoclonal antibody approved for early Alzheimer’s treatment. Eisai and Biogen’s lecanemab (Leqembi) and Biogen’s aducanumab (Aduhelm) are already on the market. However, donanemab has shown a higher incidence of ARIA compared to Leqembi, which has also been linked to patient deaths.

Despite Kisunla’s higher cost, it offers the potential to reduce out-of-pocket expenses by allowing prescribers to stop treatment if improvements are observed on brain scans. This is in contrast to Leqembi, which costs about $26,500 per year.

Addressing a Growing Crisis

The approval of donanemab comes at a critical time, as the prevalence of Alzheimer’s disease continues to rise. According to the Alzheimer’s Association, one in three older Americans dies with Alzheimer’s or another form of dementia, with the disease claiming more lives than prostate and breast cancer combined. The number of Americans aged 65 and older living with Alzheimer’s is expected to nearly double from 6.7 million in 2023 to almost 14 million by 2060.

The impact of Alzheimer’s extends beyond patients, affecting over 11 million family members and unpaid caregivers who provided approximately 18 billion hours of care in 2022. The need for effective treatments is urgent, as the burden on families and the healthcare system grows.

Moving Forward

Eli Lilly is committed to improving early detection and diagnosis of Alzheimer’s to maximize the benefits of Kisunla. Anne White, Executive Vice President and President of Lilly Neuroscience, emphasized the company’s dedication to enhancing the lives of those at risk.

The Alzheimer’s Association celebrated the FDA’s approval of donanemab, highlighting the importance of having multiple treatment options. Dr. Joanne Pike, President and CEO of the Alzheimer’s Association, stated, “This is real progress. Today’s approval allows people more options and greater opportunity to have more time. Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

As the medical community continues to strive for advancements in Alzheimer’s treatment, the approval of donanemab represents a hopeful step towards better management and care for those affected by this devastating disease.