WASHINGTON — The Food and Drug Administration on Friday 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, manufacturer Radius Health said in a statement. In postmenopausal women with osteoporosis, Tymlos is intended to reduce the risk of vertebral and nonvertebral fractures.
“Today’s FDA approval of Tymlos is an important milestone for Radius, and marks our transition to a fully integrated commercial biopharmaceutical company. I am highly confident that we have the people, strategies and resources to maximize the potential of the Tymlos franchise and deliver sustainable high performance,” said Robert Ward, president and CEO of Radius Health. “We believe that an osteoporotic fracture can be a life-altering event for a woman and her family. Osteoporosis in postmenopausal women represents a significant disease burden for which diagnosis and treatment should be healthcare priorities.”
The FDA’s approval of Tymlos was based on results at 18 months from an 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 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 bone mineral density and bone mineral content that correlated with increases in bone strength at vertebral and/or nonvertebral sites, per the study.
Waltham, Mass.-based Radius Health is a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.