Amgen received a Complete Response Letter from the FDA for the BLA for Prolia (denosumab) 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, but 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 (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 agency acknowledged receipt of Amgen’s previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia.

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

Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

“We are confident that we can quickly respond to the FDA’s requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. “Amgen is fully committed to working with the FDA to make Prolia available to patients in the near future.”

Amgen also has submitted Prolia for approval in postmenopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada. Amgen is working closely with regulatory agencies in each of these regions to make Prolia available to patients around the world.

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