FDA approves Prolia for treatment of glucocorticoid-induced osteoporosis .- Amgen.

Amgen announced that the FDA has approved the use of Prolia (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

This approval is based on data from a Phase III study which showed patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared to those who received active comparator (risedronate). The approval is supported by the 12-month primary analysis of a 24-month Phase III, randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia 60 mg subcutaneously every six months compared with oral risedronate 5 mg once daily in 795 patients receiving glucocorticoid treatment, greater than or equal to 7.5 mg/day oral prednisone (or equivalent). The study included two patient groups: a glucocorticoid-initiating subpopulation, receiving treatment for less than three months prior to study enrollment and planning to continue treatment for a total of at least six months, and a glucocorticoid-continuing subpopulation, receiving treatment for greater than or equal to three months prior to study enrollment and planning to continue treatment for a total of at least six months.

Study results showed that in the glucocorticoid-continuing subpopulation, Prolia demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (3.8 percent versus 0.8 percent, respectively) with a treatment difference of 2.9 percent (p<0.001). Similarly, in the glucocorticoid-initiating subpopulation, Prolia demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (4.4 percent versus 2.3 percent, respectively) with a treatment difference of 2.2 percent (p<0.001). Consistent effects on lumbar spine BMD were observed regardless of gender; race; geographic region; menopausal status; and baseline age, lumbar spine BMD T-score, and glucocorticoid dose within each subpopulation. Safety results were consistent with the known safety profile of Prolia.