Eli Lilly’s amyloid plaque-targeting Alzheimer’s disease (AD) drug has been approved by the US Food and Drug Administration (FDA) to treat adults with early-symptomatic cases.
Kisunla (donanemab-azbt), administered as a once-monthly intravenous infusion, has been authorised to treat patients with mild cognitive impairment or the mild dementia stage of AD with confirmed amyloid pathology.
Affecting approximately 6.9 million people in the US, AD is a progressive and ultimately fatal neurodegenerative condition that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Clinical studies have suggested that effective removal of toxic amyloid plaques in the brain can slow the cognitive deterioration of the disease.
Eisai/Biogen’s Leqembi (lecanemab), another amyloid-targeting treatment, is already approved in the US for patients with mild cognitive impairment or early-stage Alzheimer’s.
Lilly outlined that Kisunla is the first and only amyloid plaque-targeting therapy “with evidence to support stopping therapy when amyloid plaques are removed”, potentially resulting in lower treatment costs and fewer infusions.
The FDA’s decision on Kisunla comes after its Peripheral and Central Nervous System Drug Advisory Committee voted 11 to zero that the benefits of the drug outweighed its risks and that trial data submitted by Lilly showed it was effective.
Results from the late-stage TRAILBLAZER-ALZ 2 study showed that Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in AD patients who were less advanced in their disease. This was reduced to 22% for Kisunla-treated patients in the overall population, which included those with high tau levels.
Among the two groups assessed, patients receiving Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than the placebo cohort.
Anne White, executive vice president and president of Lilly Neuroscience, said: “Kisunla demonstrated very meaningful results for people with early symptomatic AD 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.”