FDA’s Full Approval of Donanamab (Kisunla), a Treatment for Alzheimer’s Disease, Comes Earlier Than Expected
In a significant development for Alzheimer's disease treatment, the U.S. Food and Drug Administration (FDA) granted full approval for Donanamab on July 2, which is marketed under the brand name Kisunla. This decision comes after months under FDA’s accelerated approval pathway and extensive clinical trials to prove efficacy and impact. This is the second viable Alzheimer’s disease treatment to be brought to market in the past few years. While considered by many a breakthrough for research progression and individuals who have been left hopeless to date by this devastating disease, there is still a long way to go in successfully combating dementia for the current diagnosis rates at a staggering 55 million individuals worldwide.
How does Kisunla slow disease progression?
Kisunla operates uniquely by targeting a key protein in Alzheimer's disease called amyloid beta. This protein forms plaques in the brain, contributing to the cognitive decline seen in Alzheimer's patients. Kisunla is administered via IV and works by binding to these plaques and facilitating their clearance from the brain. Through a phase 3 clinical trial with 1,736 participants, the study found that Kisunla was able to slow clinical decline by 35% in people with early Alzheimer's whose brain scans showed low or medium levels of a protein called tau. It is important to note that this drug had no effect in people with high tau levels.
How accessible is Kisunla?
Kisunla's approval marks a milestone in Alzheimer's treatment, providing patients and caregivers with a new option in managing this challenging disease. The drug's availability will depend on factors such as manufacturing capacity and distribution logistics, which are being addressed by Eli Lilly, the developing pharmaceutical company, in collaboration with healthcare providers.
As of now, here’s insight to access and availability of Kisunla (Donanemab):
- Prescription Requirement: Kisunla is a prescription medication used for the treatment of Alzheimer's disease. Therefore, individuals interested in accessing Kisunla need to consult a healthcare provider, such as a neurologist or a physician specializing in Alzheimer's treatment.
- Healthcare Provider Consultation: A healthcare provider will evaluate a patient's medical history, symptoms, and any existing conditions to determine if Kisunla is an appropriate treatment option. They will also discuss potential benefits, risks (learn more about the risks here), and alternatives with the patient and/or their caregivers.
- FDA Approval and Availability: While Kisunla has received approval from the U.S. Food and Drug Administration (FDA) for use in Alzheimer's disease, availability will vary based on factors such as manufacturing capacity, distribution logistics, and regional regulations. It is expected to be available in the coming weeks.
- Cost and Insurance Coverage: The total cost of this drug varies by patient based on completed treatment time; 6 months: $12,522; 12 months: $32,000; 18 months: $48,696. Coverage and out of pocket cost will depend on the length of treatment and individual insurance plans. Patients or caregivers should check with their insurance provider to understand coverage details, including copayments or any prior authorization requirements. Eli Lilly has expressed coverage and reimbursement for Kisunla is available for eligible patients on Medicare.
- Patient Assistance Programs: Pharmaceutical companies often provide patient assistance programs to help eligible individuals afford their medications. Patients or caregivers can inquire with the manufacturer of Kisunla regarding any available financial assistance or patient support programs.
The road ahead…
The FDA's approval of Donanamab as Kisunla, signifies a step forward in the treatment landscape for Alzheimer's disease and now provides patients with more than one option for consideration. It is important to note that continued research and healthcare provider education will be essential in maximizing the benefits of this new therapeutic option, as well as monitoring side effects and long-term health implications. While Kisunla represents progress in Alzheimer's treatment, research for drugs that are more affordable, more accessible, and more effective in treating a multitude of dementia forms must continue. Advancements in both research, personalized medicine, and patient-centered care are crucial in addressing the complex challenges of all forms of dementia and improving the quality of life for affected individuals and their families.
