The U.S. Food and Drug Administration on Tuesday approved Eli Lilly's treatment for early Alzheimer's, making it the second therapy for slowing progression of the brain-wasting disease that will be available to U.S. patients.
The approval for donanemab, to be sold under the brand name Kisunla, followed the recommendations of the agency's outside experts, who unanimously backed its use in patients with early Alzheimer's disease, saying the benefits of the drug outweighed its risks.
Like Eisai and Biogen's rival drug Leqembi, which was approved a year ago, donanemab is designed to clear an Alzheimer's-related protein called beta amyloid from the brain.
A key differentiating factor for donanemab is the drug's finite dosing, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques.
Lilly priced its drug at $695.65 per vial, or about $32,000 for 12-months of treatment consisting of 13 infusions.
That's slightly higher than Eisai's Leqembi, which costs $26,500 a year.