Eli Lilly Submits Clinical Trial Application for Breakthrough Alzheimer's Drug Donanemab in China

On April 8, the CDE website showed that Eli Lilly's Donanemab Injection clinical trial application was accepted for the treatment of Alzheimer's disease (AD).

Donanemab is an investigational antibody drug developed by Eli Lilly that targets a modified form of β-amyloid plaque known as N3pG. It has received Breakthrough Therapy designation from the FDA. Additionally, Eli Lilly has initiated a rolling submission for Donanemab’s marketing application to seek accelerated approval from the U.S. FDA.

In March 2021, Eli Lilly published the results of the Phase II clinical trial (TRAILBLAZER-ALZ) of this drug in the New England Journal of Medicine. Compared with placebo, Donanemab reached the primary endpoint of the Integrated Alzheimer's Disease Rating Scale (iADRS), significantly slowing the decline in the composite indicator of cognition and daily function in patients with early symptomatic Alzheimer’s disease. In June 2021, based on this data, Donanemab received Breakthrough Therapy designation from the FDA.

At the end of July 2021, Eli Lilly announced two new extended data analysis results from the TRAILBLAZER-ALZ clinical trial. The first data analysis showed that a greater reduction in amyloid plaques after Donanemab administration was highly correlated with delayed cognitive decline; participants with higher plaque clearance at week 24 experienced milder progression of tau pathology. The second data analysis demonstrated that Donanemab treatment led to a rapid decrease in biomarkers reflecting AD pathology (plasma P-tau217 protein, detectable within 12 weeks).