The U.S. Food and Drug Administration (FDA) on Tuesday approved Eli Lilly's drug for the treatment of early Alzheimer's disease, making it the second therapy available to American patients that slows the progression of this neurodegenerative disease.
The drug, named Kisunla, was approved based on unanimous recommendations from external FDA experts who believed the benefits for early Alzheimer's patients outweighed the risks.
"This is substantial progress," said Joanne Pike of the Alzheimer's Association. "Having multiple treatment options has been our long-anticipated goal, and this is an important advancement for everyone affected by this challenging and devastating disease."
Like the competing drug Leqembi, approved a year ago by Eisai and Biogen, donanemab works by clearing Alzheimer's-related proteins—beta-amyloid—from the brain.
A key distinction of donanemab is its limited dosing regimen, allowing patients to stop treatment once brain scans no longer show amyloid plaques.
Eli Lilly's drug is priced at $695.65 per vial, or about $32,000 annually, comprising 13 infusions. This is slightly higher than Eisai's Leqembi, which costs $26,500 per year.
BMO analyst Evan Seigerman said this price reflects the fact that patients can discontinue treatment, unlike Leqembi which requires long-term therapy.
Dr. Erik Musiek, a neurologist at Washington University's Barnes-Jewish Hospital, stated, "It's not clear how these details will be applied in clinical practice, but I think it will save significant costs, and patients will prefer this treatment approach."
