Eli Lilly submits Evista NDA to FDA

USA-based drug major Eli Lilly & Co says that it has completed the submission of a New Drug Application to the Food and Drug Administration that requests approval for the use of Evista (raloxifene HCl) in the treatment of invasive breast cancer. Specifically, the NDA seeks clearance for use of the drug in reducing the risk of invasive breast cancer in post-menopausal women who have osteoporosis, or who are at high risk of developing breast cancer.

The submission includes data from two pivotal clinical trials, the STAR study which examined the impact of combined tamoxifen and Evista in women at increased risk of the disease, and the RUTH assessment that measured its effect on postmenopausal women who were at increased risk of coronary disease. Additionally, the results of two supportive studies, MORE and CORE, were included in the NDA.

Lilly said that, if approved for the cancer indication, the product, which is also cleared for the treatment and prevention of osteoporosis in postmenopausal women, would be the only drug to address the two leading women's health issues.