FDA clears Amgen’s Prolia for glucocorticoid osteoporosis

The decision allows physicians to prescribe the drug to patients with a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

The approval is based on Phase III data showing that patients who received Prolia (denosumab) had greater gains in bone mineral density (BMD) compared to those who received its Actonel (risedronate).

In the study, Prolia 60mg subcutaneously every six months is being compared with oral Actonel 5mg daily in two patient subpopulations - those receiving continued glucocorticoid therapy and those starting the treatment.

Data showed that in patients receiving continuing glucocorticoid therapy Prolia led to greater gains in BMD compared with risedronate, both at the lumbar spine (4.4 percent versus 2.3 percent, respectively) and total hip (2.1 percent versus 0.6 percent, respectively).

In patients newly starting glucocorticoid treatment, Prolia also induced greater increases in BMD, both at the lumbar spine (3.8 percent vs. 0.8 percent, respectively) and total hip (1.7 percent vs. 0.2 percent, respectively).

GIOP is caused by taking glucocorticoid medicines which are commonly used to treat inflammatory diseases. Within the first three months of treatment, patient fracture risk increases up to 75 percent, although BMD will continue to decline significantly in the months to follow.

"This is a serious condition that leads to rapid decreases in bone mineral density and increased risk of fracture. This approval gives patients and physicians a new treatment option," noted Sean E. Harper, executive vice president of Research and Development at Amgen.

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