2024-07-04| Trials & Approvals

FDA Greenlights Eli Lilly’s Groundbreaking Alzheimer’s Drug Kisunla for Early Symptomatic Treatment

by Bernice Lottering
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On Tuesday, July 2, the FDA approved the Alzheimer’s drug donanemab (Kisunla). Image: GETTY IMAGES

The FDA has approved Eli Lilly and Company’s (LLY) Kisunla (donanemab-azbt), a once-monthly intravenous injection (IV), to treat adults with early symptomatic Alzheimer’s disease, including mild cognitive impairment and mild dementia with confirmed amyloid pathology. Eli Lilly highlighted that Kisunla is the first therapy targeting amyloid plaques following studies demonstrating its potential to slow disease progression. The treatment is designed to be stopped after plaque removal, which may lower costs and reduce infusion frequency. The approval marks a significant advancement in Alzheimer’s treatment, addressing both cognitive impairment and mild dementia stages.

Treatment Demonstrates Potential to Slow Alzheimer’s Progression

Kisunla represents significant progress in treating neurodegenerative disorders, targeting adults with early symptomatic Alzheimer’s disease, including those with MCI and mild dementia with confirmed amyloid plaques. Lilly reported that in the pivotal Phase 3 TRAILBLAZER-ALZ 2 trial involving 1,736 participants across eight countries, Kisunla slowed cognitive and functional decline by up to 35% over 18 months compared to placebo. Furthermore, treatment reduced the risk of disease progression by up to 39% and reduced amyloid plaque levels by 61% at six months, increasing to 84% by 18 months. Kisunla is the first treatment for amyloid plaques using a limited-duration regimen, based on plaque removal. Notably, nearly half of the trial participants completed the course of treatment within 12 months.

As part of the treatment, Kisunla is to be administered via intravenous injection once every four weeks, with each infusion lasting approximately 30 minutes. In the TRAILBLAZER-ALZ 2 trial, patients could switch to a placebo after meeting the trial goals. Priced at $695.65 per vial, the total cost of treatment varies depending on its duration. According to FDA dosing instructions, discontinuation of Kisunla may be considered once a reduction in amyloid deposition to minimal levels is observed.

These findings demonstrate the significant progress in treating neurodegenerative disorders by targeting early symptomatic Alzheimer’s disease with confirmed amyloid plaques, emphasizing Kisunla’s role in disease management through its novel, plaque-targeting approach. “We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” said Anne White, president of Lilly Neuroscience.

Long Road to Approval for Kisunla Finally Reaches Milestone

The treatment faced delays in March and a rejection in January 2023 due to insufficient data and concerns surrounding safety and efficacy. Kisunla may induce amyloid-related imaging abnormalities (ARIA), a potential side effect of amyloid plaque therapy detected via magnetic resonance imaging (MRI) scans. ARIA typically manifests as temporary brain swelling or small bleeding spots, resolving over time, although extensive bleeding is rare. Additionally, Kisunla can trigger allergic reactions, occasionally serious and life-threatening, occurring mostly during or within 30 minutes of infusion. Headaches are a common side effect as well.

Last month, an independent panel recommended FDA approval, boosting the company’s stock price. Kisunla enters the market as one of the few Alzheimer’s treatments, now competing with Biogen (BIIB) and Eisai’s Leqembi. Biogen reported a nearly tripled global in-market sales in its latest earnings report. Now, the FDA approval of Kisunla offers patients more treatment options and potentially delays the progression of Alzheimer’s disease, providing them with additional time before their health is significantly impacted. This approval represents a significant stride in tackling the challenges posed by this debilitating condition.

“Today’s approval allows people more options and greater opportunity to have more time,” Dr. Joanne Pike, the Alzheimer’s Association Chief Executive Officer (CEO) said Tuesday. “Having multiple treatment options is the kind of advancement we’ve all been waiting for—all of us who have been touched, even blindsided, by this difficult and devastating disease.”

FDA Approval of Kisunla Marks New Era in Alzheimer’s Treatment and Research

According to the Alzheimer’s Drug Discovery Foundation (ADDF), anti-amyloid drugs have the potential to set a new standard in Alzheimer’s treatment. Even after FDA approval of Kisunla, there remains a need for developing multiple novel drugs. Howard Fillit, ADDF co-founder and Chief Science Officer said “This approval is emblematic of the new era of Alzheimer’s research where we now have the first class of disease-modifying drugs that will eventually be used in combination with novel therapies—based on the biology of aging—that target all the underlying complexities of this disease.” 

With multiple FDA-approved Alzheimer’s treatments now available, early detection and diagnosis play a crucial role in maximizing treatment benefits for individuals. Access to these treatments must not face delays at any stage or by any entity. Fillit added, “This milestone will not only catalyze the next generation of therapies, but also reframe how we deliver treatments. It’s promising to see that some patients essentially enter remission, where they achieve full amyloid clearance with no resurgence in substantial plaque buildup for several years to follow.” Aducanumab, Clinical trial, Cognition, Dementia, Amyloid, kisunla drug, kisunla cost, Alzheimer’s drug, Leqembi, Donanemab, Eli Lilly, new Alzheimer’s drug, Eli Lilly stock, CAA, amyloid protein, cerebral amyloid angiopathy, amyloid plaques in the brain

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