FDA approves new Alzheimer’s drug that slows memory decline
Global News
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.
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.
“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.”
Like Eisai 4523.T and Biogen’s BIIB.O 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.
BMO analyst Evan Seigerman said the price reflects the fact that patients can stop treatment versus chronic treatment with Leqembi.
“The details of how it will play out in clinical practice are still unclear, but I think it will save a lot of money and patients will like that a lot better,” said Dr. Erik Musiek, a Washington University neurologist at Barnes-Jewish Hospital.
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