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FDA approves denosumab for treatment of postmenopausal osteoporosis

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The FDA today approved denosumab, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Denosumab (Prolia, Amgen) is a RANK Ligand inhibitor, available as a 60-mg subcutaneous injection once every six months.

The drug is indicated for women at high risk for osteoporotic fractures, including those with multiple risk factors, history of fracture and those who have failed or are intolerant to other available osteoporosis therapies.

“The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures,” Julie Beitz, MD, director of the FDA’s Office of Drug Evaluation III, said in a press release.

The safety and efficacy of denosumab was demonstrated in the three-year, phase-3 Fracture Reduction Evaluation of Denosumab in Osteoporosis (FREEDOM) study. The randomized, double blind, placebo-controlled study included 7,808 postmenopausal women aged 60 to 91 years who were randomly assigned to a 60-mg injection or placebo every six months. Compared with placebo, denosumab reduced the incidence of vertebral (68%), non-vertebral (20%) and hip (40%) fractures and was associated with significant increases in bone mineral density at all key sites mentioned.

The most common adverse events reported with denosumab include back pain, extremity pain, musculoskeletal pain, hypercholesterolemia and urinary bladder infection. Serious adverse reactions include hypocalcemia and skin reactions, such as dermatitis, rashes and eczema.

Denosumab causes significant suppression of bone turnover, which may contribute to the occurrence of osteonecrosis of the jaw, atypical fractures and delayed fracture healing.

The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of denosumab.

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