Eli Lilly And Co.
Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer's Disease Rating Scale (iADRS), measuring cognition and activities of daily living.
Earlier this year, the FDA issued a complete response letter for the accelerated approval submission of donanemab for early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.
No other deficiencies in the application were noted.
The company said that positive data from the Phase 3 TRAILBLAZER-ALZ 2 trial would form the basis of donanemab's application for traditional approval.
Donanemab treatment slowed clinical decline by 35% compared to placebo and resulted in 40% less decline on the ability to perform activities of daily living.
47% of participants on donanemab showed no decline on CDR-SB, a key measure of disease severity at one year (compared to 29% of participants on placebo).
Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo.
Donanemab significantly reduced brain amyloid plaque levels as early as six months after initiating treatment. 34% of participants in the intermediate tau population achieved amyloid clearance at six months and 71% at 12 months.
The study also enrolled a smaller number of people with high tau levels at baseline, representing a later stage of disease progression.
In this combined population, donanemab demonstrated meaningful positive results across all clinical endpoints, with CDR-SB and iADRS showing 29% and 22% slowing of decline, respectively.
