FDA approves Tymlos for postmenopausal women with osteoporosis

The FDA today approved an abaloparatide injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture, according to a press release from Radius Health.

The approval of abaloparatide (Tymlos, Radius Health) is based on results from the 18-month ACTIVE trial and the first 6 months of the ACTIVExtend trial which resulted in consistent significant reduction in the risk for vertebral fractures regardless of age, years since menopause, presence or absence of prior fracture and bone mineral density at baseline. Compared with placebo, abaloparatide reduced the risk for new vertebral fractures by 86% and the risk for nonvertebral fractures by 43%.

“Today’s Tymlos approval by the FDA is exciting since it provides physicians a new treatment option for postmenopausal women with osteoporosis which could help to rapidly, consistently and significantly increase BMD and reduce their risk of fractures,” John Bilezikian, MD, professor of medicine and pharmacology at the College of Physicians & Surgeons at Columbia University and Chief Emeritus of the division of endocrinology and director of the metabolic bone disease program at Columbia University Medical Center, said in the release. “Fragility fractures should be viewed as sentinel events which require urgent evaluation and treatment because after that first fragility fracture, patients are at greater risk for subsequent fractures. The FDA’s approval of Tymlos represents an important step in our ability to treat this serious and complex disease and, in the process, address this urgent public health crisis.”