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Amgen Says FDA Issued Complete Response Letter For BLA For Prolia In Treatment, Prevention Of Postmenopausal Osteoporosis - Quick Facts

Amgen Inc. (AMGN) said that the U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologic License Applications, or BLA, for Prolia in the treatment and prevention of postmenopausal osteoporosis.

The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval.

The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.

The FDA has determined that a Risk Evaluation and Mitigation Strategy, or REMS, is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.

Amgen said it is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.

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