Eli Lilly’s Kisunla™ Receives U.S. FDA Approval for Treatment of Early Symptomatic Alzheimer’s Disease


On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 ml intravenous infusion once monthly), Eli Lilly and Company’s (NYSE: LLY) Al Alzheimer’s disease therapy is used to treat early symptomatic Alzheimer’s disease (AD) in adults, including patients with mild cognitive impairment (MCI) and patients with mild dementia stage AD and confirmed amyloid pathology. Kisunla is the first and only therapy with evidence that it can be discontinued after amyloid plaque removal, which could lower treatment costs and reduce the number of infusions.

“Kisunla is of great significance to people with early-stage Alzheimer’s disease, who are in desperate need of effective treatments. We know that the potential benefit of these drugs is greatest when people are treated early in the disease, and we are working with Other partners work to improve detection and diagnosis of Alzheimer’s disease,” said Anne White, executive vice president of Eli Lilly and Company and president of Eli Lilly Neurosciences. “We are deeply grateful to the patients and their families who participate in our clinical programs, as well as to the Lilly scientists and partners who continue to conduct research for decades. Every year, more and more people are at risk for this disease, and we are committed to Improve their lives.”

Amyloid is a protein naturally produced by the body that can clump together to form amyloid plaques. Excessive accumulation of amyloid plaques in the brain can lead to memory and thinking problems associated with Alzheimer’s disease. Kisunla helps the body clear excessive accumulation of amyloid plaques and slows down conditions that may cause a person to have difficulty remembering new information, important dates and meetings, managing plans, cooking meals, using household appliances, managing finances, and becoming independent. .

In the Phase 2 TRAILBLAZER-ALZ study, Kisunla showed the best results in patients with the earliest stages of disease progression. During the 18-month trial, participants were divided into two groups for analysis: those with earlier disease progression (with low to moderate levels of tau protein) and the overall group, which included low, moderate and high tau levels. subjects. Treatment with Kisunla significantly slowed clinical decline in both groups. Among people with earlier disease progression, patients treated with Kisunla experienced a 35% slower rate of decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS), which includes memory, thinking and daily functioning, compared with placebo. According to the iADRS scale, in the overall population, drug treatment significantly slowed the disease by 22%. In both groups, those who received Kisunla demonstrated up to a 39% lower risk of disease progression to the next clinical stage than those who received placebo.

In the overall subject population, Kisunla reduced amyloid plaques by an average of 61% at six months, 80% at 12 months, and 84% at 18 months compared with the start of the study. One treatment goal of the study is to reduce amyloid plaques to levels consistent with a visually negative amyloid positron emission tomography (PET) scan. If the subject is confirmed to have reached this level, treatment with Kisunla is completed and switched to placebo for the remainder of the study.

Kisunla may cause imaging abnormalities associated with amyloid plaque-targeted therapies (or “ARIA”), a potential side effect that typically does not cause symptoms. It can be detected with a magnetic resonance imaging (MRI) scan, and when it occurs, it may appear as temporary swelling of an area of ​​the brain that usually disappears over time, or as small bleeding spots in or on the brain’s surface. Bleeding in larger areas of the brain occasionally occurs. ARIA can be serious and have life-threatening effects. Kisunla may also cause certain types of allergic reactions, some of which may be serious and life-threatening, usually occurring during or within 30 minutes of the infusion. Headache is another common side effect.

“This approval marks another step in advancing the standard of care for people with Alzheimer’s disease, which will ultimately include a range of novel treatments that provide much-needed hope to the Alzheimer’s community. As a “Doctors, I’m encouraged by the ability to limit treatment courses, which may reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, co-founder and chief scientific officer of the Alzheimer’s Disease Drug Discovery Foundation (ADDF). MD. express. “Being able to diagnose and treat Alzheimer’s disease earlier than we currently have is likely to significantly slow the progression of the disease, buying patients valuable time so they can remain independent longer.”

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