Eli Lilly Reports Preliminary Phase III GJAD Study Results

Eli Lilly has reported that initial results from its pivotal, five-year, phase III GJAD Generations trial for arzoxifene has met its primary endpoints of reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

However, the study failed to demonstrate a significant difference in key secondary efficacy endpoints, such as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo.

After reviewing the overall clinical profile of arzoxifene in light of currently available treatments, including Lilly’s osteoporosis products, the company has decided not to submit the compound for regulatory review. The final GJAD Generations study results will be published in 2010.

The company said that the trials will be discontinued, and the patients currently enrolled will be encouraged to speak with a healthcare professional regarding other therapeutic options.

Johnston Erwin, global brand development leader for the musculoskeletal platform at Lilly, said: At Lilly, our goal is to provide innovative therapies that result in better patient outcomes. While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the Generations data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis.