FDA Approves Eli Lilly’s Alzheimer’s Drug

The FDA has approved Kisunla, Eli Lilly’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.  Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions. 

“Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. 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, Lilly executive vice president and president of Lilly Neuroscience.

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer’s disease.  Kisunla can help the body remove the excessive buildup of amyloid plaques and slow cognitive decline.

Among the participants in the Phase 3 study, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.  One of the treatment goals of the study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography (PET). If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study.

Kisunla can cause serious side effects, including amyloid-related imaging abnormalities and infusion-related reactions. Kisunla is a prescription medicine administered intravenously every four weeks.

“This approval marks another step forward in evolving the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of novel treatments, providing much needed hope to the Alzheimer’s community. As a physician, I am encouraged by the potential to stop treatment, which could reduce out-of-pocket costs and infusion burden for eligible patients,” said Howard Fillit, M.D., Co-Founder and Chief Science Officer at the Alzheimer’s Drug Discovery Foundation. (Source: Eli Lilly Website, 02 July, 2024)