Eli Lilly and Company announced today that China’s National Medical Products Administration (NMPA) has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Lilly’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease. This includes individuals with mild cognitive impairment (MCI) and those with mild dementia who have confirmed amyloid pathology. This marks a significant step in expanding access to critical treatment for Alzheimer’s patients in China.
Kisunla’s approval in China follows similar approvals in the United States, Japan, and Great Britain. In China, it is estimated that nearly 6% of people over the age of 65 are living with Alzheimer’s disease and related dementias. By 2050, this number is expected to rise to approximately 11% of the elderly population, highlighting the urgent need for effective treatments.
“We are committed to providing Alzheimer’s disease treatment options to those facing its devastating effects. Patients and their families deserve access to amyloid-targeting therapies that can help them enjoy more time doing the things that matter most to them, particularly in the early stages of the disease,” said Ilya Yuffa, Executive Vice President and President of Lilly International, Eli Lilly and Company. “Kisunla has demonstrated meaningful results in early symptomatic Alzheimer’s disease and is now poised to improve the standard of care in China.”
Kisunla works by targeting amyloid plaques, which are clumps of a naturally occurring protein that accumulate in the brains of Alzheimer’s patients. The buildup of these plaques is linked to memory and cognitive impairments. Kisunla helps the body remove these plaques, which may slow the cognitive decline associated with Alzheimer’s disease. By targeting the root cause of cognitive issues, Kisunla can help preserve patients’ ability to remember, plan, and manage daily tasks like meal preparation, household chores, and financial management.
Notably, Kisunla is the only amyloid-targeting therapy with evidence supporting the cessation of treatment once amyloid plaques are cleared. This feature can help reduce long-term treatment costs and the frequency of infusions for patients.
TRAILBLAZER-ALZ 2 Phase 3 Study Results
Kisunla’s approval is supported by data from the TRAILBLAZER-ALZ 2 Phase 3 clinical study, which evaluated Kisunla’s efficacy and safety. In this study, the drug showed the most significant benefits for patients at the least advanced stages of Alzheimer’s, specifically those with low to medium levels of tau protein.
The study divided participants into two groups: one with low to medium tau levels, and a second with high tau levels, a marker of more advanced disease. Kisunla treatment significantly slowed clinical decline in both groups. In those with early-stage disease, Kisunla treatment led to a 35% reduction in the decline of cognitive function, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), compared to a placebo. In the overall study population, which included individuals with higher tau levels, the decline was slowed by 22%.
Additionally, participants treated with Kisunla had up to a 39% lower risk of progressing to a more advanced stage of disease compared to those receiving a placebo.
Kisunla also demonstrated a significant impact on amyloid plaque reduction. In the study, amyloid plaques were reduced by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months. One of the study’s goals was to remove amyloid plaques to minimal levels, confirmed by amyloid positron emission tomography (PET) scans. Remarkably, 66% of patients who reached this goal were able to complete treatment and switch to a placebo for the remainder of the study.
Safety Considerations
Kisunla, like other amyloid plaque-targeting therapies, can cause amyloid-related imaging abnormalities (ARIA). These abnormalities, which can include temporary brain swelling or small areas of bleeding, are typically detected through magnetic resonance imaging (MRI). Although most cases are mild and resolve over time, more serious cases of bleeding can occur. ARIA can be life-threatening, and patients receiving Kisunla should be closely monitored. Other potential side effects include allergic reactions during or shortly after infusion, and headache.
