Amgen’s Prolia approved in the USA but …


On Tuesday, the US Food and Drug Administration (FDA) approved Amgen’s RANK-L inhibitor denosumab (Prolia®) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. However, what they have not done (yet) is to approve denosumab for the treatment of bone loss associated with hormone ablation in men with prostate cancer who are also at increased risk of fractures.

A statement received from Amgen today has advised The “New” Prostate Cancer InfoLink that, “Amgen is committed to continuing to work with the FDA to make Prolia available to the appropriate patients.”

On March 28th the European Medicines Agency had approved Prolia for initial indications in the management of risk for fracture in both breast and prostate cancer. The FDA had been expected to rule on Amgen’s comparable US applications in July, so although the breast cancer approval in the US has come earlier than expected, we are going to have to wait to see what happens to the breast cancer indication.

Of course with Prolia on the market, it will be perfectly possible for physicians to prescribe this drug for appropriate patients with prostate cancer too. Whether insurance companies would be willing to pay for this use until the FDA approves that indication is a different question.

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