The US Food and Drug Administration (FDA) has approved Eli Lilly’s Kisunla, or donanemab-azbt, as a treatment for early-stage Alzheimer’s disease (AD) — including for those with mild cognitive impairment and mild dementia within the AD bracket.
The therapeutic is approved to be administered by a monthly IV infusion, with 350mg of active compound to reduce the impact of cognitive decline and amyloid plaque buildup.
Targeting amyloid plaque for the first time
Kisunla is the only Alzheimer’s therapy targeting amyloid plaque. Results from the study suggest that therapy can be stopped when the plaques are removed, which could result in a better quality of life for the patient, as well as a reduction in treatment expense.
"Kisunla demonstrated 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." said Anne White, Executive Vice President and President of Lilly Neuroscience, Eli Lilly and Company.
Promising results in the TRAILBLAZER-AD 2 Phase III trial
During the study period, it was observed that patients with less advanced disease responded significantly better to those who were further on in pathological progression. The 18-month period of treatment reduced cognitive decline in early-stage patients by 35% compared to placebo, while reducing the risk of disease progression by up to 39%.
Additionally, at the end of 18 months, 84% of patients enrolled in the overall population experienced a reduction in amyloid plaques — the presence of which is a key disease feature of Alzheimer’s.
"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 Co-Founder and Chief Science Officer at the Alzheimer's Drug Discovery Foundation, Howard Fillit. "Diagnosing and treating Alzheimer's sooner than we do today has the potential to meaningfully slow disease progression, giving patients invaluable time to maintain their independence for longer."