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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Tymlos (abaloparatide)

Indication:

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

Mechanism:

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

Dosage:

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

Approval:

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.

References:

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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