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Amgen to Discuss Denosumab Data at Today's Advisory Committee for Reproductive Health Drugs
Date:8/13/2009

THOUSAND OAKS, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today will summarize data from the submitted Biologic License Applications (BLAs) for denosumab for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in breast and prostate cancer patients undergoing hormone ablation at a meeting with the U.S. Food and Drug Administration's (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD).

"There remains a need for additional alternatives to treat postmenopausal osteoporosis, and there are no currently approved treatments for bone loss due to hormone ablation therapy," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Based on efficacy and safety data from 30 studies involving 12,000 patients, Amgen believes that denosumab would offer a meaningful treatment option for patients with these conditions."

Amgen will discuss the efficacy, safety and overall benefit:risk profile of denosumab, and will propose an approach to post-marketing surveillance and risk management should the FDA decide to approve denosumab for commercial use.

The ACRHD will discuss the use of denosumab in each of four indications outlined in the BLAs:

  • Treatment of osteoporosis in postmenopausal women
  • Prevention of osteoporosis in postmenopausal women
  • Treatment and prevention of bone loss associated with hormone ablation in patients with breast cancer
  • Treatment and prevention of bone loss associated with hormone ablation in patients with prostate cancer

"Denosumab has a positive benefit:risk profile in these patient populations, and we look
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SOURCE Amgen Inc.
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