FDA/CDC

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.

FDA icon Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License
Common adverse events with abaloparatide include hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo. Abaloparatide was shown to increase risk for osteosarcoma in rats, with higher doses further increasing risk. While it is not known whether abaloparatide will cause osteosarcoma in humans, usage of Tymlos in patients at increased risk for osteosarcoma is not recommended.

Find the full statement on the Radius Health website.

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