FDA Approves Lilly's Kisunla To Treat Early Symptomatic Alzheimer's Disease

(RTTNews) - The U.S. Food and Drug Administration approved Eli Lilly and Co.'s (LLY) Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), the company's Alzheimer's treatment for adults with early symptomatic Alzheimer's disease, which includes people with mild cognitive impairment as well as people with the mild dementia stage of Alzheimer's disease, with confirmed amyloid pathology.

The company noted that Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%.

Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months, the company said.