How effective is donanemab (donanemab-azbt)-Kisunla?

The U.S. Food and Drug Administration (FDA) announced the approval of donanemab (donanemab-azbt)-Kisunla for the treatment of Alzheimer's disease (AD). Kisunla is produced by Eli Lilly. Results from a Phase 3 clinical trial called TRAILBLAZER-ALZ 2 were published in 2023, showing that Kisunla slowed the rate of cognitive and functional decline in participants with early symptoms of Alzheimer's disease.

The TRAILBLAZER-ALZ 2 trial enrolled participants aged 60 to 85 years with early symptomatic Alzheimer's disease (specifically mild cognitive impairment or Alzheimer's disease mild dementia). Trial results were consistent with primary and secondary endpoints measuring cognition and function. Clinical decline was slowed by 22.3% in the combination group compared with the placebo group. The incidence of serious adverse events was 17.4% of patients who received donelumab and 15.8% of patients who received placebo.

Specifically, 47% of those who received the drug showed no signs of cognitive decline after one year of treatment, compared with 29% of those who received a placebo. Kisunla is an antibody developed by Eli Lilly to reduce the harmful effects of beta-amyloid, a protein commonly found in the brains of people with Alzheimer's disease.

Alzheimer's disease and related dementias are complex diseases caused by a series of overlapping and intertwined biochemical reactions that damage the brain. Successfully treating dementia may require a different set of preventive and diagnostic therapies for each person. The data reported in these Kisunla studies suggest that anti-amyloid therapies may be at least a first step in many other treatments.