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.