Eli Lilly and Co. received approval from the FDA for its osteoporosis drug Evista 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.

Evista, a selective estrogen receptor modulator or SERM (recently classified by the FDA as an estrogen agonist/antagonist), is currently approved for the prevention and treatment of osteoporosis in postmenopausal women. The approval was based on data submitted in November 2006 in a 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.