Lilly drops arzoxifene filing after mixed Ph III results

US drug major Eli Lilly says that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for its post-menopausal osteoporosis drug arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

However, the study failed to demonstrate a statistically-significant difference in key secondary efficacy endpoints, such as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo. In addition, certain adverse effects, including venous thromboembolic events, hot flushes and gynecological-related events, were reported more frequently in the arzoxifene group compared with placebo.

After reviewing the overall clinical profile of arzoxifene in light of currently available treatments, including Lilly's own 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.