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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

sal phase of their lives, the incidence of certain diseases, such as invasive breast cancer and osteoporosis, increases dramatically," said Steven Cummings, M.D., emeritus professor of medicine and epidemiology and biostatistics at the University of California San Francisco. "Therefore, it's important for postmenopausal women to be aware of these serious risks and have treatment choices to address them."

The FDA evaluated a data package that included multiple trials assessing three different populations of postmenopausal women:

-- The Study of Tamoxifen and Raloxifene (STAR) trial, sponsored by the National Cancer Institute (NCI) and coordinated by the National Surgical Adjuvant Breast and Bowel Project (NSABP), involved postmenopausal women at increased risk for invasive breast cancer. The observed incidence rates of invasive breast cancer were EVISTA 4.4 and tamoxifen 4.3, per 1000 women per year.

-- The Raloxifene Use for The Heart (RUTH) trial looked at postmenopausal women with known or at increased risk for coronary disease. The study demonstrated that EVISTA significantly reduced the risk of invasive breast cancer in postmenopausal women by 44 percent with an absolute risk reduction of 0.6 percent.

-- The Multiple Outcomes of Raloxifene Evaluation (MORE) and Continuing Outcomes Relevant to Evista (CORE) trials evaluated postmenopausal women with osteoporosis. Both four-year trials showed that EVISTA reduced the risk of invasive breast cancer in women by 71 percent with an absolute risk reduction of 1.1 percent, and 56 percent with an absolute risk reduction of 1.0 percent, respectively.

Important Safety Information About EVISTA(R)

EVISTA is not for everyone. If you are or still can become pregnant, are nursing, or have had blood clots that required a doctor's treatment, you cannot take EVISTA. An infrequent but serious side effect of EVISTA is blood clots in the veins - being immobile for a long time may add to the risk.'/>"/>

SOURCE Eli Lilly and Company
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