INDIANAPOLIS (dpa-AFX) - 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.



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