Eli Lilly has successfully obtained FDA approval for its Alzheimer’s disease medication, Kisunla, a drug with similar therapeutic mechanisms to Eisai’s Alzheimer’s treatment but offers distinct dosing benefits that may attract patient preference. This approval follows unanimous support from an FDA advisory committee, recognizing Kisunla’s capability in decelerating cognitive decline outweighs its associated safety risks.
Kisunla, previously known as donanemab during its development phase, targets patients with mild cognitive impairment or mild dementia due to Alzheimer’s—exactly the group examined in its pivotal clinical trials. The drug operates by targeting and reducing amyloid beta plaques, one of the primary pathological features of Alzheimer’s disease, within the brain.
The backbone of Lilly’s FDA submission was a placebo-controlled Phase 3 trial involving 1,736 patients, all confirmed to have amyloid plaques with mild cognitive symptoms. The core purpose of the trial was to monitor any changes in a clinical rating scale designed to evaluate cognitive and functional abilities in Alzheimer’s patients over an 18-month period. Remarkably, the outcomes revealed a significant 35% reduction in cognitive decline for patients with low-to-medium levels of tau protein, and a 22% reduction in the broader study group, both statistically significant achievements. Additionally, Kisunla appeared to effectively diminish the risk of disease progression by 39% when compared to placebo.
The trial also had objectives beyond cognitive assessment, including monitoring the clearance of amyloid deposits from the brain. Encouraging results showed a substantial clearing of these plaques by 61% at six months, 80% at 12 months, and peaking at 84% at 18 months. In an innovative approach, once patients achieved a predefined level of amyloid clearance, they were transitioned from Kisunla to a placebo for the study’s remainder.
Despite initial regulatory hiccups—including a preliminary FDA rejection in early 2023 due to insufficient data from patients treated for at least 12 months—Lilly managed to collect the necessary information and resubmitted its application last summer. Following an advisory panel review, which aligned with earlier assessments of similar antibody treatments by Biogen and Eisai, the drug was finally approved, a development much celebrated within the Alzheimer’s community.
Beyond its clinical impact, Kisunla introduces new considerations in the treatment administration and pricing structure. It is administered as a 30-minute infusion once a month, allowing some patients to cease therapy after achieving sufficient amyloid clearance, contrary to the continuous bi-weekly hourlong infusions required by Eisai’s Leqembi. This potentially shorter treatment duration could reduce overall patient exposure to the drug, lowering the risks associated with long-term treatment. Kisunla’s pricing is set at $695.65 per vial, with the final treatment costs varying based on patient weight and required duration—ranging from $12,522 for a six-month course to nearly $49,000 for an 18-month regimen. These figures underscore the complicated financial aspect of Alzheimer’s treatment, dependent on individual therapeutic needs and insurance coverage.
Adding to the complexity, Kisunla’s labeling includes a black box warning highlighting the potential for severe brain bleeds and inflammation, risks that are generally associated with this class of Alzheimer’s drugs. The labeling also flags an increased risk for those carrying the ApoE 4 gene.
The Kisunla approval not only expands the arsenal against Alzheimer’s but also shifts traditional treatment parameters, offering a model where therapy can be tailored and potentially shortened based on individual patient responses—an advance that could influence future therapeutic strategies across the spectrum of neurodegenerative diseases.
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