FDA approves abaloparatide for postmenopausal osteoporosis

The Food and Drug Administration has approved abaloparatide (Tymlos) for postmenopausal women with osteoporosis at high risk for fracture.

Abaloparatide was approved based on 18-month results from the ACTIVE trial and 6-month results from the ACTIVExtend trial. Patients in the ACTIVE trial showed an relative risk reduction of 86% for new vertebral fractures and 43% for nonvertebral fractures, compared with placebo, according to a statement from manufacturer Radius Health. Results were similar regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density at baseline.

^{Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License}

Find the full statement on the Radius Health website.

lfranki@frontlinemedcom.com