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FDA Greenlights Eli Lilly's Anti-Amyloid Alzheimer's Drug Kisunla

NextEdge Admin

03 Jul 2024

3 min 27 sec

The US Food and Drug Administration (FDA) granted approval to Eli Lilly's drug Kisunla (donanemab) for treating Alzheimer's disease, marking a significant development in combating this neurodegenerative condition. Kisunla is a monoclonal antibody administered monthly via intravenous infusion. It targets beta-amyloid plaques in the brain, a key characteristic of Alzheimer's disease, aiming to slow disease progression by removing these plaques.

The approval is specifically for patients in the early stages of symptomatic Alzheimer's disease confirmed by amyloid pathology. Unlike other treatments like Eisai and Biogen's Leqembi, which require ongoing maintenance dosing, Kisunla allows for treatment cessation once a certain level of beta-amyloid plaque removal is achieved, as determined by PET imaging.

FDA's decision was informed by data from the TRAILBLAZER-ALZ 2 Phase III clinical trial, where patients receiving Kisunla showed a 22% slowing of Alzheimer's progression on the integrated Alzheimer's Disease Rating Scale (iADRS) compared to those on placebo. Additionally, there was a 29% slowing on the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB).

Lilly noted that Kisunla demonstrated the most significant impact in patients with early-stage disease, particularly those with higher tau levels, another biomarker associated with Alzheimer's progression.

Despite its effectiveness, Kisunla carries risks, including amyloid-related imaging abnormalities (ARIA), which can cause temporary brain swelling or bleeding. While typically asymptomatic, ARIA can be severe. Lilly and FDA have emphasized the importance of careful monitoring during treatment.

Anne White, Lilly Neuroscience's executive VP, highlighted the potential benefits of early intervention with Kisunla, stressing the importance of improving detection and diagnosis of Alzheimer's to maximize treatment impact.

The Alzheimer's Association welcomed Kisunla's approval as a step forward but cautioned on the need for equitable access to these breakthrough therapies. They called on healthcare providers to share real-world data through initiatives like the Alzheimer's Network for Treatment and Diagnostics to better understand how diverse patient populations respond to these new treatments.

Kisunla's approval represents a promising advance in Alzheimer's treatment, offering hope to patients and families affected by this devastating disease while underscoring the ongoing challenges in ensuring broad access and monitoring safety in real-world settings.