FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Tymlos (abaloparatide)


Treatment of postmenopausal women with osteoporosis at high risk for fracture.


Synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP) that, among other functions, regulates bone formation.


80 mcg SC once daily. Supplement with calcium and vitamin D if dietary intake is inadequate.


Approval was based on results at 18 months from the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and first 6 months of the ACTIVExtend trial. In the ACTIVE trial of more than 2000 women, subcutaneous abaloparatide was associated with significant reductions in the relative risk for new vertebral fractures (86% reduction) and nonvertebral fractures (43% reduction) compared with placebo. In the ACTIVExtend trial, roughly 1100 patients who completed 18 months of abaloparatide or placebo in ACTIVE received open-label alendronate for up to 24 additional months. Data from the first 6 months of ACTIVExtend showed improved bone mineral density and reduced fracture risk throughout the skeleton.


Miller PD, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial. JAMA. 2016 Aug 16;316(7):722-33.

Cosman F, et al. Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: results of the ACTIVExtend trial. Mayo Clin Proc. 2017 Feb;92(2):200-10.


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