FDA Approves Donanemab for Alzheimer’s Treatment, Offering a New Hope for Early-Stage Patients

Alzheimer’s disease, a progressive degenerative disorder that affects memory and cognitive function, has seen significant advancements in its treatment with the approval of donanemab by the US Food and Drug Administration (FDA). The drug, containing an antibody designed to slow the progression of the disease, works by removing amyloid protein plaque buildup in the brain. Lilly, the manufacturing company, announced that the drug will be sold under the name kisunla and will cost $32,000 per year.

Clinical trials have demonstrated that donanemab can slow down Alzheimer’s disease progression, allowing some patients to remain independent for longer periods and engage in daily activities. In June 2021, Lilly presented late-stage clinical trial data to FDA advisors showing a 35% lower risk of disease progression in patients taking donanemab compared to those receiving a placebo. After considering both safety and effectiveness, FDA advisors determined that the treatment is suitable for use. However, there were some serious side effects reported during trials, including a higher mortality rate among donanemab users compared to placebo takers. As a result of this concern, additional brain MRI tests are now being added for patients to identify potential risks of bleeding prior to treatment.

Alzheimer’s disease is a debilitating condition that often leads to death within 10-15 years of diagnosis. Donanemab offers hope for early-stage Alzheimer’s patients by providing another option for managing their condition. This development marks a significant milestone in Alzheimer’s treatment research and provides patients and healthcare providers with another important tool to combat this devastating disease.