FDA Approves Lilly's Kisunla for Early Alzheimer's

The FDA has recently approved Eli Lilly's amyloid plaque-targeting therapy, donanemab-azbt, now marketed under the name Kisunla, for adults with early symptomatic Alzheimer's disease. This approval sets up a competitive landscape with Eisai and Biogen's Leqembi (lecanemab). Kisunla will be administered as a once-monthly infusion, and the initial list price is set at $32,000 for 12 months of treatment. However, the actual cost will depend on the duration of use. For instance, some participants in clinical trials ceased treatment after six months, guided by brain scan results, while others continued for up to 18 months, leading to an increased cost of $48,696. In comparison, Leqembi, which received full FDA approval about a year ago, was launched at an annual list price of $26,500.

Kisunla is indicated for adults experiencing mild cognitive impairment or mild dementia due to Alzheimer's disease with confirmed amyloid pathology. This approval is grounded in findings from the Phase III TRAILBLAZER-ALZ 2 study, which showed significant benefits in slowing both cognitive and functional decline. Notably, Kisunla represents the first amyloid plaque-targeting therapy that utilizes a limited-duration treatment regimen based on the removal of amyloid plaque. Nearly half of the study participants completed their treatment course within 12 months.

The journey to market approval for Kisunla was not without its challenges. Initially, Eli Lilly sought accelerated approval based on Phase II findings. However, the FDA rejected this proposal last year, prompting Lilly to file a traditional application based on the TRAILBLAZER-ALZ 2 data. Adding to the complexities, the FDA made a last-minute decision in March to convene a panel of external advisors, a move that Eli Lilly did not anticipate given the advanced stage of the review process.

Despite these hurdles, an FDA advisory panel recently voted unanimously in favor of Kisunla's safety and efficacy, concluding that the benefits of the drug outweigh its risks. This approval highlights the evolving landscape of Alzheimer's treatments and introduces a new option for patients with early symptomatic Alzheimer's disease.