Due in part to safety concerns as well as certain study results, Eli Lilly & Co. will not seek FDA approval for its developing menopausal osteoporosis drug, arzoxifene.
According to the company, the drug met late-stage study goals of reducing the risk of vertebral fracture and invasive breast cancer, but failed to meet several secondary goals including cognitive function and non-vertebral fractures.
Moreover there were serious safety concerns over increased risk of blood clots as well as gynecological-related events.
More than 9,354 postmenopausal women were involved in the 5-year study.
"The results of arzoxifene’s Generations study serve as a reminder of the high risks associated with pharmaceutical innovation," said Eli Lilly Chairman and CEO John Lechleiter, in a statement.