The Food and Drug Administration (FDA) has approved Eli Lilly and Co's (NYSE:LLY) new Alzheimer’s drug, donanemab, to be sold under the brand name Kisunla.
This monoclonal antibody infusion, administered every four weeks, targets amyloid in the brain, a hallmark of Alzheimer’s disease. Clinical trials showed Kisunla slowed the progression of Alzheimer’s by about 35% over 18 months, compared to a placebo.
Kisunla is approved for adults with mild cognitive impairment or early Alzheimer’s disease. The FDA's decision is based on a late-stage clinical trial involving 1,700 participants. Kisunla's approval provides another treatment option alongside Leqembi, a similar drug approved last summer.
Medicare is expected to cover Kisunla, priced at $32,000 for a 12-month supply. The Centers for Medicare and Medicaid Services will require physicians to collect data on the drug's real-world performance. Kisunla’s approval follows a unanimous recommendation from the FDA’s advisory committee.