On October 26, Eli Lilly published its report on the third-quarter 2021 financial results, summarising key earnings and revenue figures and detailing advances in regulatory submissions for drugs in indications such as type 2 diabetes, heart failure and atopic dermatitis.
The company also announced that it had initiated rolling submission of a biologics licence application for donanemab to the US Food and Drug Administration (FDA), for accelerated approval in early Alzheimer's disease. Donanemab is an investigational antibody therapy that targets amyloid plaques in the brain for clearance by the immune system, and is delivered via monthly intravenous infusions. Results of the TRAILBLAZER-ALZ study, which recruited 272 participants with early-stage, symptomatic Alzheimer's disease, were published in the New England Journal of Medicine in May 2021. These results showed some improvement for primary outcomes of cognition and activities of daily living after 76 weeks, but mixed results on secondary outcomes in similar areas.
The company also announced plans to conduct a Phase 3 head-to-head clinical trial comparing donanemab to Biogen's anti-amyloid drug, aducanumab. The goal of this trial, called TRAILBLAZER-ALZ 4, is to assess superiority of brain amyloid plaque clearance in early symptomatic Alzheimer's disease. Enrollment is expected to begin this year. To find out more:
