Kisunla Approved to Treat Alzheimer’s Disease

On July 2, 2024, the U.S. Food and Drug Administration (FDA) granted full approval for Eli Lilly’s Kisunla^™ (donanemab-azbt) for the treatment of adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Kisunla is an amyloid beta-directed antibody that is administered by intravenous (IV) infusion. The recommended dose is 700mg administered over 30 minutes every four weeks for the first three doses, followed by 1,400mg doses every four weeks. Patients can discontinue treatment with Kisunla if an amyloid positron emission tomography (PET) scan shows minimum levels of amyloid plaque. Nearly half of patients in a key clinical trial were able to discontinue therapy after 12 months. The cost for a 12-month treatment course is $32,000. The labeling for Kisunla contains a boxed warning concerning the risk for amyloid-related imaging abnormalities (ARIA), which can potentially lead to rare – but life-threatening events – such as brain swelling and bleeding. Lilly plans to launch Kisunla within a few weeks. Full prescribing information can be found here.

At a Glance

• Brand Drug: Kisunla^™ (donanemab-azbt)
• Manufacturer: Eli Lilly and Company
• Date Approved: July 2, 2024
• Indication:  to treat adults with early symptomatic Alzheimer’s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease
• Dosage Forms Available: 350mg/20mL (17.5mg/mL) in single-dose vials
• Launch Date: Within a few weeks
• Estimated Annual Cost: $32,000 for a 12-month treatment course; length of treatment/cost varies based on a patient’s amyloid plaque level
• AD is the most common form of dementia. According to the Alzheimer’s Association, there are nearly seven million Americans with AD.
• Although its onset may be earlier for some individuals, Alzheimer’s disease symptoms generally begin around age 65 years – usually with forgetfulness and trouble making decisions.
• Over several years, brain function gradually deteriorates — leading to increased cognition difficulties, behavioral changes and physical symptoms. Patients in advanced stages are unable to care for themselves.
• For reasons that currently are not understood, Alzheimer’s disease is caused by abnormal protein deposits in the brain. Accumulations of proteins known as amyloid beta plaques, damage brain cells and blood vessels. Tau proteins, which also build up in the brains of patients who have Alzheimer’s disease, twist nerve cells into distinctive “tangles”.
• Kisunla works by decreasing accumulations (plaques) of amyloid proteins in the brain.
• Approval was based on results from the 18-month TRAILBLAZER-ALZ 2 phase III study that demonstrated that Kisunla slowed clinical decline by 22% in treated patients.
• Symptomatic ARIA occurred in 6% of patients in the clinical trial. To monitor for ARIA, brain magnetic resonance imaging (MRI) should be obtained before starting treatment with Kisunla and prior to the second, third, fourth and seventh infusions.
• Other common side effects include headaches and infusion-related reactions.
• Eisai/Biogen’s Leqembi^® (lecanemab-irmb) is an amyloid beta-directed monoclonal antibody that received accelerated approval in January 2023 and full approval in July 2023 for treating early AD. It is administered as an IV infusion every two weeks. Leqembi costs about $26,500 per year. Approvals of Leqembi for IV dosing every four weeks and subcutaneous (SC) dosing every week are expected by Jan. 25, 2025.
• Aduhelm^® (aducanumab-avwa – Biogen/Eisai) was the first amyloid beta-directed monoclonal antibody to receive accelerated approval in June 2021 for treating AD. In January 2024, Biogen announced that it had discontinued Aduhelm for business reasons.