FDA Approves Abaloparatide for Fragility Fracture in Postmenopausal Women With Osteoporosis

bone osteoporosis fracture
bone osteoporosis fracture
Tymlos approval was based on the results of the ACTIVE and ACTIVExtension trials.

The US Food and Drug Administration (FDA) has approved abaloparatide (Tymlos™; Radius Health) injection for postmenopausal women with osteoporosis at an increased risk of fracture, according to a press release.1

Abaloparatide approval was based on results of the ACTIVE (Study to Evaluate the Safety and Efficacy of BA058 [Abaloparatide] for Prevention of Fracture in Postmenopausal Women; ClinicalTrials.gov Identifier: NCT01343004) and ACTIVExtend (Twenty Four Month Extension Study of BA058-05-003; ClinicalTrials.gov Identifier: NCT01657162) trials,2,3 both of which demonstrated significant and rapid reduction in patients’ risk of vertebral and nonvertebral fractures, regardless of age, years since menopause onset, or baseline bone mineral density.

Throughout the phase 3 ACTIVE trial, patients treated with abaloparatide demonstrated “significant reductions in the relative risk of new vertebral and nonvertebral fractures compared [with] placebo,” according to the press release (absolute risk reductions, 3.6% and 2%, respectively).

John Bilezikan, MD, professor of medicine and pharmacology, director of the metabolic bone diseases program at Columbia University Medical Center in New York City, and study investigator, noted that the abaloparatide approval “provides physicians a new treatment option … which could help to rapidly, consistently, and significantly increase bone mineral density and reduce the risk of fractures.”

Abaloparatide may increase patients’ risk of osteosarcoma, orthostatic hypotension, hypercalcemia, hyperalciuria, and urolithasis. Additional adverse reactions include dizziness, nausea, palpitations, fatigue, upper abdominal pain, and vertigo. Use for more than 2 years throughout a patient’s lifetime is not recommended.

Abaloparatide will be available beginning June 2017.

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  1. FDA approves Radius Health’s TYMLOS™ (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture [press release]. Waltham, MA: Radius Health. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=1023557. Published April 28, 2017. Accessed May 9, 2017.
  2. Miller PD, Hattersley G, Riis BJ, et al; for the ACTIVE Study Investigators. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis. JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136
  3. Cosman F, Miller PD, Williams GC, et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis. Mayo Clin Proc. 2017;92(2)200-210. doi:10.1016/jmayocp.2016.10.009