> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Lilly Eyes Fast OK for Donanemab in Alzheimer’s
- URL: https://www.fdaweb.com/lilly-eyes-fast-ok-for-donanemab-in-alzheimers/
- Published: 2023-05-03T12:00:00.000Z
- Updated: 2026-09-14T18:29:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154358

Buoyed by positive results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease, Lilly [says](https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional?ref=fdaweb.com) it anticipates a regulatory submission to FDA this quarter and will work with the agency to achieve the fastest path to traditional approval. Earlier this year, FDA [issued](https://www.fdaweb.com/lilly-alzheimers-bla-rejected-by-fda/) a complete response letter to a Lilly BLA for accelerated approval for donanemab, citing the limited number of patients with at least 12 months of drug exposure data provided in the submission. The company reported there were no other deficiencies cited.

Lilly says donanemab met the primary endpoint and all secondary endpoints in the trial.

“In addition to slowing cognitive and functional decline in TRAILBLAZER-ALZ 2, donanemab produced significant reductions in brain amyloid plaque levels as early as six months after initiating treatment,” Lilly says. “These Phase 3 data confirm the benefit observed in our TRAILBLAZER-ALZ study and show that donanemab, if approved, may represent a significant step forward for people with early symptomatic Alzheimer’s disease and allow them to continue to participate in activities that are meaningful to them.”