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Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
Date:8/13/2009

THOUSAND OAKS, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) issued the following statement on the outcome of today's meeting with the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) to review the potential use of Prolia(TM) (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer.

After reviewing safety and efficacy data from 30 clinical studies involving more than 12,000 patients, the Committee recommended approval of Prolia for the treatment of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation for prostate cancer. The Committee recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until additional data are available.

The Committee also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations.

Finally, the panel recommended that Prolia have a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide and a healthcare provider communications plan.

The FDA often seeks the advice of an advisory committee such as the ACRHD when evaluating a potential new treatment but is not required to follow its recommendation.

Postmenopausal osteoporosis is a major public health concern resulting in fractures that cause significant clinical morbidity, mortality, and healthcare burden, and there remains a need for additional treatment alternatives. Similarly, bone loss due to hormone ablation in the setting of
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SOURCE Amgen Inc.
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