Eli Lilly had said on January 11 that the 32% decline rate, compared to placebo, was 'statistically significant' and met the primary endpoint of phase 2 'Trailblazer' ALZ study. "Given our ...

The FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly and Company’s (NYSE:LLY) Phase 3 TRAILBLAZER-ALZ 2 trial ...

Last year in March, Eli Lilly released the results of the TRAILBLAZER-ALZ 2 Phase 3 study of donanemab for Alzheimer’s disease. Donanemab treatment slowed clinical decline by 35% compared to ...

The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer’s drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker.

The recent FDA complete response letter to Eli Lilly and Company about donanemab ... to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion." Topline data on ...

Last year in March, Eli Lilly released the results of the TRAILBLAZER-ALZ 2 Phase 3 study of donanemab for Alzheimer's disease. Get stock picks, daily rankings, and pro-level trading tools in one ...

Eli Lilly’s bid for an accelerated approval ... Donanemab is currently in a phase 3 trial called TRAILBLAZER-ALZ 2 that Lilly hopes will do just that. A top-line readout is expected in the ...

The company said its Phase 3 Trailblazer-Alz2 study remains on track to read out in June. If the results are positive, Eli Lilly will apply for traditional approval. Unlike some previous FDA decisions ...

Eli Lilly and Company. “We anticipate this study will confirm the benefit and safety profile we observed in the TRAILBLAZER-ALZ phase 2 study and believe that patients and physicians will be ...

Eli Lilly (NYSE:LLY) has received regulatory ... The approval was backed by data from the company’s late-stage trials TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6, which tested donanemab in more ...