Lilly Ends Arzoxifene Program

After a five-year Phase III study, Lilly has decided not to submit arzoxifene to regulatory authorities. The osteoporosis treatment met its primary endpoints in the trial, but failed to demonstrate efficacy against placebo in the secondary endpoints. In addition, some adverse events occurred more frequently than in the placebo.

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

“The results of arzoxifene’s [Phase III] study serve as a reminder of the high risks associated with pharmaceutical innovation,” commented John Lechleiter, Ph.D., Lilly’s chairman and chief executive officer.

The drug significantly reduced the risk of vertebral fracture and invasive breast cancer in postmenopausal women, but was no better than placebo at such endpoints as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function. The trial’s results will be published in 2010.

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