FDA Approves Eli Lilly's Donanemab for Early Alzheimer's, Marking Significant Progress

The U.S. FDA approved Eli Lilly's early Alzheimer's treatment, Donanemab, which will be sold as Kisunla. It follows expert recommendations, offering another option for patients. The drug aims to clear beta-amyloid protein from the brain and is priced at $695.65 per vial, with a year of treatment costing $32,000. However, it has risks of brain swelling and bleeding.

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 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.

"This is real progress," said Joanne Pike of the Alzheimer's Association. "Having multiple treatment options is the kind of advancement we've all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease." Donanemab is designed to clear an Alzheimer's-related protein called beta amyloid from the brain. The drug is priced at $695.65 per vial, but the total cost of the treatment will depend on the number of monthly infusions required to clear a patient's amyloid. A 12-month treatment consisting of 13 infusions would cost $32,000, the company said.

Data from a large clinical trial showed the drug slowed the progression of memory and thinking problems by 29%. Drugs of this type, including Eisai and Biogen's rival drug Leqembi, are associated with swelling and bleeding in the brain.

In Lilly's trial, donanemab caused brain swelling in nearly a quarter of patients and brain bleeding in nearly a third of patients, though most cases were mild. The FDA placed its strongest "boxed" safety warning on the prescription label, flagging donanemab's risk of potentially dangerous brain swelling and bleeding.

The agency added a similar caution label for Leqembi when it was approved last year. Eisai and Biogen's first Alzheimer's drug, Aduhelm, won an accelerated approval from the agency in 2022, but its efficacy was uncertain and the companies abandoned the drug in early 2024. (Reporting By Deena Beasley in Los Angeles and Bhanvi Satija and Mariam Sunny in Bengaluru; Editing by Bill Berkrot)

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