The FDA has asked Amgen to submit additional data and undertake further clinical study to gain approval for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The agency also requested all updated safety data related to Prolia.
Amgen expects to receive a separate complete response letter for its BLA related to Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
The letter pertaining to Prolia in postmenopausal osteoporosis requested further information on the design of Amgen's previously submitted postmarketing surveillance program. This letter does not require additional premarketing clinical trials to complete the review of the treatment indication. The FDA also asked for a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis.
Additionally, FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS.