Lilly's Alzheimer’s drug Kisunla wins FDA approval

The US Food and Drug Administration (FDA) approved Eli Lilly’s ((NYSE: LLY) Kisunla (donanemab-azbt), once-monthly injection for IV infusion), Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

Lilly said that once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.

It is a long-awaited win for Eli Lilly after donanemab faced obstacles in its path to market not really expected, and marks the third treatment for AD cleared by the FDA, after Leqembi (lecanemab) and an ill-fated therapy called Aduhelm (aducanumab), both from Japanese drugmaker Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB).