Donanemab, now marketed as Kisunla, is a monoclonal antibody that targets a brain plaque called amyloid. It's intended to treat mild cognitive impairment from early-stage Alzheimer's and is administered monthly by intravenous infusion.
The drug will be available in the coming weeks, Lilly said.
Anti-amyloid drugs can significantly reduce the levels of a sticky plaque in the brain called amyloid beta, but questions remain about the clinical significance and degree of benefit.
There were serious risks identified in the trial, raising concerns that the risk outweighed the benefit. Three people died after developing serious brain bleeding or swelling.
Donanemab is not a cure, but clinical trials showed that it slowed the progression of Alzheimer's.
According to Lilly, donanemab slowed Alzheimer's disease progression by 35 percent relative to placebo treatment, in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease. In practical terms, that translated to delaying progression by about four months.
The price of each vial of Kisunla is $695.65, Lilly said, which equates to $32,000 for a year. The actual cost will depend on how long patients take the treatment, though Medicare Part B will cover it and provide some reimbursement.
Donanemab is the second amyloid-targeting Alzheimer's drug on the market now, but it's the third to get the green light from FDA since 2021.
Biogen and Eisai jointly developed Aduhelm and Leqembi, though Aduhelm was plagued by controversy from the start and was discontinued in January. The FDA approved the drug through an accelerated pathway despite a negative recommendation from an advisory panel.
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