WASHINGTON -- The FDA has approved denosumab (Prolia), a fully human monoclonal antibody, for treatment of postmenopausal women who have a high risk for osteoporotic fractures, including those with a history of fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapy.
Denosumab is the first RANK ligand inhibitor to receive FDA approval. Recommended dosing is a 60 mg subcutaneous injection every six months.
The approval was based on data from a three-year randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, denosumab reduced the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
Denosumab is known to cause significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a factor that raised concern at an FDA advisory panel last August.
Other common side effects reported with denosumab include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections.
Serious adverse reactions include hypocalcemia, serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.
The FDA approval requires a risk evaluation and mitigation strategy (REMS) that includes a medication guide for patients and communications to healthcare providers that explain the risks and benefits of the drug.
Denosumab is manufactured by Amgen Manufacturing, a subsidiary of Thousand Oaks, Calif.-based Amgen.