Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved its osteoporosis drug Evista (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 women 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 (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, MD, 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. 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. The American Cancer Society estimates that approximately 180,000 women are diagnosed with invasive breast cancer each year.

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

"As women age and enter the postmenopausal phase of their lives, the incidence of certain diseases, such as invasive breast cancer and osteoporosis, increases dramatically," said Steven Cummings, MD, 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: