Eli Lilly's Alzheimer's disease treatment donanemab receives breakthrough therapy designation

Today, Eli Lilly and Company (Eli Lilly and Company) announced that its research on Alzheimer's disease (AD) antibody therapy donanemab has received a breakthrough therapy designation granted by the US FDA

Donanemab is a monoclonal antibody that binds to the beta amyloid subtype N3pG

▲Donanemab is designed to specifically bind to amyloid deposits in the brain to promote their removal

The grant of this breakthrough therapy designation is based on the clinical evidence of donanemab in the Phase 2 clinical trial TRAILBLAZER-ALZ

The results of the trial showed that after 76 weeks of treatment, the reduction in iADRS scores of patients treated with donanemab was 32% less than that of the placebo group (p=0.

▲IADRS scores of AD patients treated with donanemab decreased more slowly than the placebo group

At the same time, positron electron scanning (PET) imaging showed that donanemab can quickly remove amyloid deposits in the patient’s brain

Eli Lilly is currently conducting a randomized, double-blind, placebo-controlled Phase 3 clinical trial to further test the safety, tolerability and efficacy of donanemab

Reference materials:

[1] Lilly's donanemab receives US FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease.

[2]Therapeutic development for Alzheimer's disease at Eli Lilly and Company.

[3]Mintun et al.