Prolia approved for postmenopausal osteoporosis

PROLIA (denosumab) 60mg subcutaneous injection by Amgen
PROLIA (denosumab) 60mg subcutaneous injection by Amgen
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.