FDA Approves Evista For Postmenopausal Osteoporosis
INDIANAPOLIS, IN. -- October 1, 1999 -- Eli Lilly and Company (NYSE: LLY) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to market Evista for the treatment of postmenopausal osteoporosis, a disease that threatens approximately 23 million American women. Much of the data supporting this FDA submission were recently published in the Journal of the American Medical Association.
This marks the second U.S. indication for Evista, which was first approved nearly 2 years ago for use in the prevention of osteoporosis in postmenopausal women. Evista is the only selective estrogen receptor modulator (SERM) on the market to both prevent and treat postmenopausal osteoporosis, a debilitating disease.
"Lilly is pleased to provide for women a new therapy option to treat osteoporosis and help reduce the risk of fractures," said Hunter Heath III, M.D, Medical Director of US Endocrinology, Lilly. "Preventing fractures can significantly reduce the burden of pain and disability among women with osteoporosis."
Findings from the ongoing Multiple Outcomes of Raloxifene Evaluation (MORE) trial, a multicenter study involving 7,705 women with osteoporosis, were the basis for the FDA treatment submission. MORE was designed primarily to evaluate the effects of drug therapy on spinal fracture risk and bone mineral density (BMD). Administered once daily, Evista decreased the incidence of spinal fracture by about half. Evista also significantly increased spine and hip BMD compared with placebo.
Approximately every 30 seconds in the U.S., one osteoporotic fracture occurs among women. One in two women over the age of 50 will suffer an osteoporotic fracture during her lifetime.
To date, Evista is approved for use in 59 countries worldwide, primarily for the prevention of postmenopausal osteoporosis. Lilly is in the process of filing treatment submissions to regulatory bodies worldwide. Lilly continues to support research to evaluate the effects of Evista on diseases beyond osteoporosis.
Of course, Evista is not for everyone. Evista is contraindicated for women who are or can become pregnant or are nursing, have severe liver problems, or have blood clots that required a doctor's treatment. An infrequent but serious side effect of Evista is blood clots in the veins. The most commonly reported side effects were hot flashes and leg cramps. However, most women taking Evista did not experience these symptoms.
Evista is a registered trademark of Eli Lilly and Company.
Related Links: Eli Lilly and Company.
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