Eli Lilly & Co. (NYSE: LLY) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for donanemab as a treatment for adults with early symptomatic Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) and individuals with mild AD-related dementia, confirmed to have amyloid pathology. The drug will be marketed under the trade name Kisunla. This approval comes after Phase III data from July 2023 demonstrated that donanemab, administered as a 350 mg/20 mL once-monthly injection for IV infusion, slows the progression of Alzheimer’s disease in its early stages, reducing the risk of patients advancing to the next clinical stage by up to 39%.
The approval has been highly anticipated. Initially, Lilly filed for accelerated approval based on Phase II data in Q2 2022, but the FDA issued a complete response letter (CRL) in January 2023, opting to await full Phase III data and employing the traditional approval pathway due to safety concerns.
Kisunla is the third anti-amyloid Alzheimer’s therapy to receive market approval, following Biogen and Eisai’s Aduhelm (aducanumab), which has since been withdrawn, and Eisai’s Leqembi (lecanemab). Unlike its predecessors, Kisunla’s treatment is discontinued once amyloid plaque removal is confirmed, translating to lower treatment costs and fewer infusions.
The approval was supported by the Phase III TRAILBLAZER-ALZ 2 double-blind, placebo-controlled study, which involved 1,736 patients across eight countries, with a primary endpoint of least-square mean (LSM) change in the integrated Alzheimer Disease Rating Scale (iADRS) score. The study included patients with low/medium tau pathology (68.1%; n = 1182) and high tau pathology (31.8%; n = 552). Those in the low/medium group experienced the most significant benefits, with donanemab treatment resulting in a 35.1% reduction in disease progression compared to placebo, while the overall population saw a significant 22.3% reduction.
Patients who achieved minimal levels of amyloid plaque by PET scan were able to discontinue treatment, with 17% completing treatment at 6 months, 47% at 12 months, and 69% at 18 months. Lilly has indicated that it plans to launch Kisunla priced at USD 695.65 per vial, making treatment costs variable depending on when patients achieve minimal amyloid plaque levels, ranging from USD 12,522 at 6 months to USD 32,000 at 12 months, or USD 48,696 at 18 months.
In China, Lilly filed for donanemab approval in October 2023, and the drug was granted priority review status in November that year.- Flcube.com
