The U.S. Food and Drug Administration (FDA) has approved a new drug called donanemab for the treatment of early symptomatic Alzheimer’s disease. This significant development brings hope to many patients and their families. Developed by Eli Lilly, a pharmaceutical company based in Indianapolis, donanemab is designed to slow the progression of Alzheimer’s by targeting amyloid plaque buildup in the brain. This plaque is a hallmark of the disease and contributes to its devastating effects.

Donanemab, marketed under the name Kisunla, is a monoclonal antibody that helps the body remove amyloid plaques from the brain. While it is not a cure for Alzheimer’s, clinical trials have shown that it can slow the progression of the disease, allowing patients to maintain their independence and continue participating in daily activities for a longer period.

Clinical Trial Results

In clinical trials, donanemab demonstrated impressive results. The data showed that patients who received the drug had about a 35% lower risk of disease progression over 18 months than those who received a placebo. This means that the drug significantly slowed the worsening of symptoms in those who took it. The FDA’s panel of advisors reviewed these findings and concluded that donanemab is safe and effective.

However, like all medications, donanemab is not without risks. During the clinical trials, some patients experienced serious side effects, including amyloid-related imaging abnormalities (ARIA). ARIA involves small brain haemorrhages and can be a serious condition. Three participants in the trial died after developing ARIA. Despite this, the incidents were rare, occurring in only 2% of patients. To minimize these risks, Eli Lilly added additional MRI screenings to detect early signs of ARIA and pause treatment if necessary.

Cost and Accessibility

Kisunla is priced at $695 per vial before insurance, which amounts to about $12,522 for a six-month course or approximately $32,000 for a year of treatment. Eli Lilly has indicated that treatment might be paused if patients show improvement in brain scans, potentially reducing overall costs.

Donanemab is not the first monoclonal antibody approved for Alzheimer’s treatment. Other drugs, such as Eisai and Biogen’s lecanemab (sold as Leqembi) and Biogen’s aducanumab (marketed as Aduhelm), have also received FDA approval. Aduhelm was the first such therapy to obtain accelerated approval in 2021, but Biogen plans to discontinue its production to focus on other treatments. In trials, Leqembi was also associated with ARIA but at lower rates than donanemab.

Impact on Alzheimer’s Care

The approval of Kisunla is a major step forward in the fight against Alzheimer’s. The Alzheimer’s Association has expressed strong support for this new treatment option. Dr. Joanne Pike, the association’s president and CEO, emphasized the importance of having multiple treatment options. She stated, “This is real progress. Today’s approval allows people more options and greater opportunity to have more time.”

The Growing Need for Alzheimer’s Treatments

Alzheimer’s disease affects a significant portion of the ageing population. As of 2023, about 6.7 million Americans aged 65 and older live with Alzheimer’s. The number of people with the disease is expected to nearly double to almost 14 million by 2060, according to the U.S. Centers for Disease Control and Prevention (CDC). The disease not only impacts patients but also places a heavy burden on their families and caregivers. In 2022, over 11 million family members and unpaid caregivers provided an estimated 18 billion hours of care for people with Alzheimer’s and other dementias.

Future Directions

Eli Lilly is committed to improving early detection and diagnosis of Alzheimer’s. Anne White, executive vice president and president of Lilly Neuroscience, stated, “Each year, more and more people are at risk for this disease, and we are determined to make life better for them.” The company is working with others to enhance early detection, which is crucial for the effectiveness of treatments like donanemab.

The approval of donanemab represents a significant milestone in Alzheimer’s treatment. While it is not a cure, it offers hope by slowing the progression of the disease and allowing patients to maintain their quality of life for longer. The Alzheimer’s Association and advocates for patients view this as a critical step forward. As the prevalence of Alzheimer’s continues to rise, the development of effective treatments remains a top priority. The approval of Kisunla provides a promising new option for those affected by this devastating disease.