FDA approves Tymlos (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis and high fracture risk.- Radius Health

Radius Health, Inc. has announced that the FDA 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 density. 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 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.

Comment: Competitors include Prolia (denosumab) from Amgen and now generic Forteo (terparatide) from Eli Lilly. Aboloparatide is likely to be more effective and safer than Forteo.It was ahead in trial progression to the Prolia successor, romosozumab, which is in Phase III for osteoporosis and aboloparatide is approved first.