The FDA has approved Prolia (denosumab, from Amgen) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. This approval was based on data from a Phase 3 three-year study in 7,808 postmenopausal women with osteoporosis. Treatment with Prolia demonstrated a 68% reduction in vertebral fractures, a 40% reduction in hip fractures, and a 20% reduction in non-vertebral fractures. Additionally, significant bone density increases were observed: 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck.
Prolia inhibits the RANK ligand, an essential regulator of osteoclasts. Prolia will be available later this month as a 60mg subcutaneous injection that is administered every six months.
For more information call (800) 77-AMGEN or visit www.amgen.com.