Lilly execs target top spot in Alzheimer's market post-Kisunla FDA approval

Eli Lilly's recent FDA approval for its Alzheimer's treatment Kisunla (donanemab) marks a significant milestone in the battle against Alzheimer's disease. This approval allows Kisunla to be used for treating adults with early symptomatic Alzheimer's disease (AD). This achievement comes after more than three decades of research and development by Eli Lilly, which also involved creating diagnostic tools to detect amyloid plaque in the brain, according to Dawn Brooks, Eli Lilly's global development leader for Alzheimer's disease.

Kisunla's approval adds a new dimension to the Alzheimer's treatment landscape, which had already seen the introduction of Eisai and Biogen’s Leqembi (lecanemab). Both therapies require the confirmation of amyloid beta pathology in patients’ brain tissue before treatment. With Kisunla, patients now have a second option, potentially transforming the early treatment phase of Alzheimer's disease. Andrew Lechleiter, VP of U.S. Alzheimer’s disease marketing at Lilly, remarked that this could be the "end of the beginning in treating this disease."

Before Kisunla's approval, Eli Lilly concentrated on preparing the market for a new Alzheimer's treatment by developing diagnostic tools and raising awareness about amyloid's role in impairing memory and cognition. They have educated healthcare providers and imaging centers on using amyloid PET scans and other biomarker tests for diagnosing AD. Lechleiter emphasized the need to foster a sense of urgency among consumers through disease education and other campaigns aimed at physicians.

While a competitive landscape with Eisai and Biogen is anticipated, Lilly aims to not only compete but also lead in creating a modern Alzheimer's treatment ecosystem. Despite Leqembi's full FDA approval last year, there remains a significant unmet need among early Alzheimer’s patients. Lechleiter stated that Alzheimer's disease itself is the main competitor they need to focus on, emphasizing the priority of building the market for effective treatments.

Kisunla’s introduction comes at a favorable time as the Centers for Medicare and Medicaid Services (CMS) last summer revised its strict national coverage determination for amyloid-targeting Alzheimer’s medications. Although this adjustment doesn't guarantee an entirely smooth path forward, it removes a significant barrier, Lechleiter explained. CMS has planned to broadly cover new Alzheimer's medications like Kisunla and Leqembi upon their full FDA approval, with a stipulation that drugmakers must collect real-world data to support their products' ongoing value.

Lechleiter expressed optimism that the Medicare registry portal will quickly include new customers, aiming to ensure a seamless reimbursement process for clinics and institutions using Kisunla appropriately. He acknowledged that there still might be hurdles such as high out-of-pocket costs for some patients and geographical challenges in accessing necessary diagnostics.

Kisunla offers potential advantages over Leqembi, such as the convenience of monthly infusions rather than biweekly. Moreover, patients may be able to discontinue treatment once they achieve reduced amyloid levels. Brooks highlighted findings from Lilly’s TRAILBLAZER trial, where some patients could stop treatment as early as six months in, with continued cognitive benefits observed over the 18-month study period.

Lilly is also conducting a long-term extension study to monitor Kisunla's effects on patients' cognitive functions over time. Brooks noted that amyloid re-accumulation happens slowly, suggesting that patients might avoid re-treatment for several years after initial successful therapy.

Looking ahead, Lilly is working on the TRAILBLAZER ALZ-3 study to explore whether Kisunla can prevent Alzheimer's disease symptoms before they start, with primary results expected in October 2027.