What Does Kisunla Treat?
Kisunla (donanemab) is FDA-approved for the treatment of adults with early symptomatic Alzheimer's disease, specifically patients with mild cognitive impairment (MCI) or mild dementia stage of disease. 1, 2
Indication and Patient Population
- Kisunla received traditional FDA approval on July 2,2024, as an amyloid plaque-lowering monoclonal antibody for early-stage Alzheimer's disease. 1
- The medication is specifically indicated for patients in the early symptomatic phase, encompassing those with MCI or mild dementia due to Alzheimer's disease. 2, 3
- This represents the third amyloid-directed monoclonal antibody to receive FDA approval, following aducanumab (Aduhelm) and lecanemab (Leqembi). 1
Mechanism of Action
- Kisunla is classified as an anti-amyloid immunotherapy that works by targeting and reducing amyloid-β (Aβ) plaques in the brain. 3, 4
- As a second-generation monoclonal antibody, donanemab is directed against pathogenic Aβ species and aggregates, distinguishing it from first-generation antibodies that targeted non-toxic monomeric Aβ. 4
- The medication reduces both the burden of amyloid in the brain and clinical decline as measured by cognitive assessments. 3
Clinical Context and Requirements
- Providing treatment with Kisunla requires high proficiency, sufficient resources, and close collaboration with comprehensive multidisciplinary teams. 1
- The availability of this disease-modifying therapy creates demand for timely detection, accurate diagnosis, and appropriate treatment options that may overwhelm unprepared healthcare systems. 1
- Companion diagnostic biomarkers (such as amyloid PET or CSF assays) are necessary to confirm amyloid pathology before initiating treatment. 1
- Brain MRI scans are required for monitoring amyloid-related imaging abnormalities (ARIA), including ARIA-E (vasogenic edema) and ARIA-H (cerebral microhemorrhages), which are important side effects. 1, 3
Important Caveats
- Kisunla is NOT indicated for patients with moderate to severe dementia, only early-stage disease. 2, 3
- The medication requires registration in a CMS-approved patient registry for Medicare reimbursement, similar to lecanemab. 1
- New models of hub-and-spoke dementia specialist-primary care collaborations are needed to address workforce gaps in delivering this therapy. 1