FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Gives Nod to Radius Health’s Osteoporosis Drug Tymlos

May 8, 2017
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Radius Health has gained FDA approval for Tymlos (abaloparatide) injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture, multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

In postmenopausal women with osteoporosis, the drug reduces the risk of vertebral and nonvertebral fractures.

The approval was based on clinical trial results showing significant and rapid reductions in the risk of vertebral and nonvertebral fractures regardless of age, years since menopause, presence or absence of prior fracture and bone mineral density at baseline.

The drug has also been shown to increase BMD and to increase a marker of bone formation.

Tymlos will be available in the United States in June.

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