NEW YORK – The US Food and Drug Administration on Tuesday approved Eli Lilly's beta-amyloid-targeting drug Kisunla (donanemab) as a treatment for Alzheimer's disease.
Kisunla is a monoclonal antibody delivered monthly through an intravenous infusion and indicated for patients with early-stage symptomatic Alzheimer's disease that is confirmed based on amyloid pathology. The drug is designed to slow disease progression by removing beta-amyloid plaques in the brain, a hallmark of Alzheimer's.
The list price for a vial of Kisunla is $695.65.
Patients would stop Kisunla infusions after reaching a certain threshold of beta-amyloid plaque removal, as measured by PET imaging, according to Indianapolis-headquartered Lilly. Kisunla's dosing contrasts with Eisai and Biogen's Leqembi (lecanemab), the only other anti-amyloid Alzheimer's treatment on the market, for which the companies have proposed ongoing maintenance dosing.
The FDA last month convened an advisory committee to weigh in on whether Lilly's drug had proven effective in clinical trials, and committee members unanimously voted that it had.
To reach its decision, the FDA reviewed data from the randomized-controlled TRAILBLAZER-ALZ 2 Phase III clinical trial, in which investigators observed slower disease progression from baseline to 76 weeks in patients treated with Kisunla compared to those who received a placebo. On the integrated Alzheimer's Disease Rating Scale (iADRS), there was a 22 percent slowing of Alzheimer's progression among Kisunla-treated patients and a 29 percent slowing of disease progression on the Clinical Dementia Rating-Sum of Boxes scale (CDR-SB).
Kisunla appeared to slow disease progression most effectively in patients at an earlier stage of disease, based on tau levels, another protein biomarker associated with Alzheimer's, Lilly said.
"We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis," Anne White, executive VP and president of Lilly Neuroscience, said in a statement.
Kisunla can cause side effects including amyloid-related imaging abnormalities (ARIA), which manifest as temporary swelling or bleeding in patients' brains. Although ARIA is typically asymptomatic, it can be serious and life-threatening. ARIA has also been linked with other drugs in this class.
Joanne Pike, president and CEO of the Alzheimer's Association, a group focused on advancing research into the neurodegenerative disease, celebrated Kisunla's approval as "real progress," but noted that the field is a long way from ensuring equitable access to these treatments. The association urged prescribers to join the Alzheimer's Network for Treatment and Diagnostics and share real-world data on how patients from different backgrounds and communities respond to the latest FDA-approved Alzheimer's drugs.