Amgen's Prolia Complete Response submission: FDA classifies and sets PDUFA date

Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia™ (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.

In October 2009, the FDA's Division of Reproductive and Urologic Products issued a Complete Response Letter for the Biologic License Application (BLA) for Prolia in the treatment and prevention of postmenopausal osteoporosis. The letter requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA also requested all updated safety data related to Prolia. Amgen submitted the requested information for the treatment indication in late January 2010.

Amgen continues to work with the FDA to determine appropriate next steps regarding its indications for Prolia in the prevention of postmenopausal osteoporosis, as well as in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

SOURCE Amgen

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