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FDA Approves Lilly's Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
Date:9/14/2007

First treatment approved to reduce invasive breast cancer risk in

postmenopausal women with osteoporosis

INDIANAPOLIS, Sept. 14 /PRNewswire-FirstCall/ -- Today, Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved its osteoporosis drug EVISTA(R) (raloxifene HCl) for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.

"The FDA's decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns -- osteoporosis and invasive breast cancer," said Gwen Krivi, Ph.D., vice president of Lilly Research Laboratories. "Further, postmenopausal women at high risk for invasive breast cancer will have an alternative therapy for invasive breast cancer risk reduction."

EVISTA, a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist), is already approved for the prevention and treatment of osteoporosis in postmenopausal women. In July, the Oncologic Drugs Advisory Committee (ODAC) to the FDA voted to recommend approval for the new uses. Today's decision and the positive recommendation from ODAC were based on data submitted in November 2006 in a new drug application (NDA), evaluating clinical results from approximately 37,000 postmenopausal women that spanned nearly 10 years.

Earlier this year, the osteoporosis label for EVISTA was updated to include safety information from the Raloxifene Use for The Heart (RUTH) trial, which evaluated postmenopausal w
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