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FDA Panel Recommends Approval Of Prolia To Treat Postmenopausal Osteoporosis And Bone Loss In Prostate Cancer Patients Undergoing Hormone Ablation

Amgen Inc. (AMGN) said Thursday that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration has recommended approval of
Prolia for the treatment of postmenopausal osteoporosis and the treatment of bone loss in patients undergoing hormone ablation for prostate cancer.

However, the 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, Amgen said. 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, which could include a medication guide and a healthcare provider communications plan.
The FDA often seeks the advice of an advisory committee when evaluating a potential new treatment but is not required to follow its recommendation.

The FDA has targeted an FDA action within ten months of the application's submission date, resulting in a Prescription Drug User Fee Act action date of October 19.

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