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: New York City Personal Injury LawyerEli Lilly Will Not Seek FDA Approval For Menopausal Osteoporosis Drug
By Chrissie Cole
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.
Originally posted at InjuryBoard by Chrissie Cole
Full post as published by New York City Personal Injury Lawyer on August 20, 2009 (boomark / email).
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