New Injectable Osteoporosis Drug Approved

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has approved abaloparatide (marketed as Tymlos) for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture — that is, those who have had a prior osteoporotic fracture, have multiple fracture risk factors, or have failed or cannot tolerate other osteoporosis therapies.

The osteoanabolic agent is a synthetic analog of human parathyroid hormone (PTH)-related protein. Approval was based on findings from a placebo-controlled, phase III trial in which abaloparatide reduced the incidence of new vertebral fracture by 86% over an 18-month period. The drug also cut the risk for nonvertebral fracture by 43%. Teriparatide, a previously approved recombinant PTH, showed similar benefits in the same trial.

Abaloparatide is given as a daily, subcutaneous injection. Like teriparatide, its label carries a warning about a potentially increased risk for osteosarcoma.