NEW YORK (AP) — Eli Lilly & Co. said Tuesday it will not seek FDA approval for its developing postmenopausal osteoporosis drug because of certain study results and safety concerns. The company said the drug met its late-stage study goals of reducing the risk of vertebral fracture and invasive breast cancer, but failed to meet a variety of secondary goals, such as cognitive function and non-vertebral fractures. Meanwhile, there were some serious safety concerns over increased risk of blood clots and gynecological-related events. The five-year study involved 9,354 postmenopausal women. “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. The Indianapolis company expects to book a third-quarter charge of about 3 to 4 cents per share associated with costs for shutting down the program. Still, the company expects full-year profit between $4.20 and $4.30 per share, excluding charges. Analysts on average expect a profit of $1.01 per share for the third quarter and $4.28 per share for the full year.
