The FDA ( US Food and Drug Administration ) has approved Tymlos ( Abaloparatide ) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
In postmenopausal women with osteoporosis, Tymlos reduces the risk of vertebral and nonvertebral fractures.
The FDA's approval of Tymlos was based on results at 18 months from the landmark ACTIVE trial and first six months of ACTIVExtend trial that demonstrated consistent significant and rapid reductions in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture ( vertebral or nonvertebral ) and bone mineral density ( BMD ) at baseline.
In human clinical studies, Tymlos has been shown to decrease the incidence of new vertebral and nonvertebral fractures, to increase bone mineral density, and to increase a marker of bone formation.
In addition, the anabolic effect of Tymlos was demonstrated in animal studies by increases in BMD and bone mineral content that correlated with increases in bone strength at vertebral and/or nonvertebral sites.
The results from the ACTIVE trial were published in the Journal of the American Medical Association ( JAMA ) in August of 2016, and the results of the first six months of ACTIVExtend were published in the Mayo Clinic Proceedings in February 2017.
Specifically, in the ACTIVE trial, Tymlos demonstrated significant reductions in the relative risk of new vertebral and nonvertebral fractures compared to placebo in the ACTIVE trial of: 86% in new vertebral fractures; 43% in nonvertebral fractures.
The absolute risk reductions were 3.6% and 2.0%, respectively.
The Phase 3 ACTIVE ( Abaloparatide Comparator Trial In Vertebral Endpoints ) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of Abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures.
ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of Abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label Alendronate. ( Xagena )
Source: Radius Health, 2017