Donanemab

Drug Information

Donanemab (Kisunla™) is a new monoclonal antibody that targets brain amyloid-β(p3-42) plaques. It is delivered as an infusion at predetermined doses once a month for up to 18 months. Patients may have the option to stop treatment upon reaching a threshold clearance of amyloid beginning after 9 months of treatment. The FDA has fully approved donanemab for eligible patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease.

Eligibility

The drug has been studied in patients with mild cognitive impairment due to Alzheimer’s disease or mid Alzheimer’s disease. Its effects in patients without cognitive impairment or moderate-to-severe Alzheimer’s disease are unknown.

Safety

The most common side effects are infusion-related, including headache and ARIA (ARIA-E, edema or ARIA-H, hemorrhage); MRI brain imaging shows swelling or bleeding in the brain. If the reaction is mild or moderate in the extent of the bleeding or swelling, the patient may be required to suspend treatment. Adverse effects are more common in Alzheimer’s patients who carry the APOE ε4 (APOE4) gene.

Efficacy

In the Phase 3 TRIALBLAZER-ALZ trial, donanemab demonstrated its capability to clear amyloid plaques and indicated the potential to slow cognitive decline in patients with early symptomatic Alzheimer’s disease. Utilizing standardized rating scales designed to assess cognitive and functional outcomes in Alzheimer’s disease trials, donanemab slowed decline by 28.9%. This effect corresponds to a delay in symptom progression of 4.5 to 7.5 months.

Cost

Donanemab is currently marketed at $32,000 a year for a person of average weight. Additional costs associated with using this drug include amyloid biomarker assessments (e.g., amyloid-PET), genetic testing, and serial brain MRIs to monitor safety.

Medicare Coverage

Medicare coverage is available for donanemab for patients who are enrolled in a registry that is approved by the Centers for Medicare & Medicaid Services (CMS). More information will be added as it becomes available.

Ongoing Clinical Trials

Donanemab Phase 3 TRIALBLAZER-ALZ patients will continue to be studied in multiple clinical trial sites to evaluate the ongoing safety and efficacy of the medication. For more information, please visit ClinicalTrials.gov ID: NCT05026866.

Clinic

To learn more about Alzheimer’s disease treatment and care at UCLA, please speak with your primary care doctor or call the UCLA Amyloid Immunotherapy Care Program at (310) 963-2592.