Lilly’s Alzheimer’s Drug Shows Promise in Phase 3 Trial

Following hot on the heels of FDA approval for the Biogen/Eisai Alzheimer’s drug Leqembi, Eli Lilly presented results from its Phase 3 study of donanemab which showed that the drug significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s. The data were shared at the 2023 Alzheimer’s Association International Conference as a featured symposium and simultaneously published in the Journal of the American Medical Association.

Lilly had previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study. Submission to the FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are currently underway, and the majority will be completed by year end.

Donanemab specifically targets deposited amyloid plaque and has been shown to lead to plaque clearance in treated patients regardless of the stage of disease. Among all study participants, treatment with donanemab reduced amyloid plaque on average by 84% at 18 months, compared with a 1% decrease for participants on placebo.

In the earlier stage of disease, treatment with donanemab resulted in 47% of participants with no progression at one year versus 29% on placebo. Those participants treated with donanemab also had a 39% lower risk of progressing to the next clinical stage of disease over the 18-month trial. This delay in progression meant that, on average, participants treated with donanemab had an additional 7.5 months before they reached the same level of cognitive and functional decline compared to those on placebo. (Source: Eli Lilly Website, 17 July, 2023)