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FDA Expands Indication of Osteoporosis Drug


May 22, 2018

The US Food and Drug Administration has approved a fifth indication of Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis in men and women with a high risk of fracture.

The approval was granted following the success of a Phase 3 study involving 795 glucocorticoid-treated participants. Each participant was placed in 1 of 2 groups: a glucocorticoid-initiating subpopulation, and a glucocorticoid-continuing population.

Results of the study demonstrated that participants in both groups who received 60 mg Prolia every 6 months had greater gains in lumbar bone mineral density compared with those who received 5 mg oral risedronate once daily (3.8% vs 0.8%, respectively).

Safety results from this study were consistent with the known safety profile of Prolia. The most commonly reported adverse reactions with Prolia were back pain, hypertension, bronchitis, and headache.

Prolia is also approved in the United States for the following:

  • To treat postmenopausal women with a high risk for fracture.
  • To increase bone mass in men with osteoporosis with high fracture risk.
  • To increase bone mass in women receiving adjuvant aromatsase inhibitor therapy for breast cancer with a high risk of fracture.
  • To increase bone mass men receiving androgen deprivation therapy for non-metastatic prostate cancer with high fracture risk.

—Christina Vogt


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