There are still risks of using the drug.
The U.S. Food and Drug Administration recently approved a new drug, donanemab (marketed as Kisunla), for the treatment of early symptomatic Alzheimer’s disease. This medication has shown modest effectiveness in slowing cognitive decline in clinical trials, which is crucial for patients in the early stages of this debilitating condition. However, donanemab also carries significant risks, such as brain swelling and bleeding.
Anne White, executive vice president and president of Lilly Neuroscience, emphasized the importance of early intervention in Alzheimer’s treatment and expressed optimism about Kisunla’s potential impact. She highlighted Lilly’s ongoing efforts to enhance detection and diagnosis of the disease to maximize therapeutic benefits.
The approval of Kisunla was met with enthusiasm from Alzheimer’s advocates, who view it as a step toward advancing care standards and offering hope to patients. Dr. Howard Fillit, from the Alzheimer’s Drug Discovery Foundation, praised the approval as part of an evolving landscape that may significantly delay disease progression and preserve patients’ independence longer.
Kisunla operates similarly to another drug, Leqembi, approved last year for Alzheimer’s treatment, both targeting the amyloid protein implicated in the disease’s development. These drugs have shown comparable efficacy in slowing dementia progression by several months, with Kisunla administered monthly via intravenous infusion, offering a potential advantage in treatment convenience.
Unique to Kisunla is its capability to be discontinued once all amyloid plaques are cleared from the brain, potentially reducing treatment costs, inconvenience, and associated side effects. Clinical trials indicated that a significant proportion of patients were able to stop the drug after achieving plaque clearance, with continued cognitive benefits observed even after cessation.
Despite these advancements, concerns persist about the drug’s affordability and safety profile. Kisunla’s annual list price of $32,000 underscores accessibility challenges, while notable side effects, including brain-related complications linked to rare fatalities, warrant careful consideration.
Looking forward, the field of Alzheimer’s research remains active, with ongoing clinical trials exploring drugs targeting tau tangles, neuroinflammation, and other disease mechanisms. Some experts caution against an exclusive focus on anti-amyloid therapies, urging continued exploration of diverse treatment avenues to accelerate progress in Alzheimer’s care.
In summary, while Kisunla represents a significant advancement in Alzheimer’s treatment, its approval marks a pivotal moment in ongoing efforts to combat this devastating disease, balancing therapeutic promise with critical safety considerations and the need for broader treatment accessibility.
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