FDA approves injectable Kisunla for early symptomatic Alzheimer’s disease

The FDA approved Kisunla for adults with early symptomatic Alzheimer’s disease, including those with mild cognitive impairment and mild dementia with confirmed amyloid pathology.

In a press release, Eli Lilly & Company said the amyloid-targeting treatment was green-lighted in a 350 mg/20 mL formulation to be administered as a once-a-month injection whose infusion would last approximately 30 minutes.

Approval by the regulatory body came less than a month since the Peripheral and Central Nervous System Drugs Advisory Committee unanimously ruled in favor of Kisunla (donanemab-azbt), saying the 30-minute infusion treatment was effective in treating individuals with mild cognitive impairment and mild dementia forms of the condition, despite the possibility of patients developing amyloid-related imaging abnormalities.

“We are no longer asking whether or not we can diagnose Alzheimer’s, but, rather, how early can we detect the disease?” Howard Fillit, MD, co-founder and chief science officer at the Alzheimer’s Drug Discovery Foundation, told Healio in an email. “With the validation of new biomarkers, especially blood tests, we can now diagnose the disease with ease and intervene earlier than ever, including in the preclinical phase, opening the door (to) prevention.”

The FDA’s decision was based on results from the phase 3 TRAILBLAZER-ALZ 2 clinical trial, in which those who were least advanced in the AD disease course experienced the greatest results with Kisunla.

According to statistics cited in the release, in the total study population Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months and 84% at 18 months compared to baseline.

Participants treated with Kisunla who were less advanced in their disease showed a slowing of decline 35% greater than those given placebo as measured by the integrated Alzheimer's Disease Rating Scale, which measures memory, thinking and daily functioning.

Additionally, enrollees treated with Kisunla experienced an up to 39% lower risk of progressing to the next clinical stage of disease compared with those taking placebo.

"Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease, who urgently need effective treatment options,” Anne White, executive vice president and president of Lilly Neuroscience, Eli Lilly & Company, stated in the release. “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.”