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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

omen with known or at increased risk for coronary disease taking EVISTA. This trial found no increase in the incidence of stroke, but an increase in the incidence of death due to stroke.

Since the new label for EVISTA(R) (raloxifene HCl) includes new uses and an expanded patient population, Lilly worked with the FDA to revise the package insert, which will now include a boxed warning. The warning highlights information already included in the Contraindications and Warnings & Precautions sections of the prior label. It emphasizes that women with an active or past history of venous thromboembolism should not take EVISTA and that women at risk for stroke should receive EVISTA only after evaluating the risk-benefit balance with their healthcare providers.

"Thousands of women each year are diagnosed with invasive breast cancer," said Dr. Lawrence Wickerham, M.D., associate chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and associate professor of human oncology at Drexel University School of Medicine. "Today's approval of EVISTA for these new uses gives postmenopausal women at risk for this disease an important new treatment option that allows them to take a proactive approach to reducing their risk."

While the exact causes of breast cancer are unknown, certain risk factors are linked to the disease, including age, family history, personal history of breast cancer, genetics and lifestyle factors(1). The increased incidence of breast cancer as women age is notable, as nearly eight out of 10 breast cancers are found in women age 50 and older(2). The American Cancer Society estimates that approximately 180,000 women are diagnosed with invasive breast cancer each year(3).

In addition, age is an important risk factor associated with osteoporosis. According to the National Osteoporosis Foundation, approximately 55 percent of people affected by osteoporosis are age 50 and over(4).

"As women age and enter the postmenopau
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SOURCE Eli Lilly and Company
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