FDA Clears Abaloparatide for High-Risk Osteoporosis Patients

Megan Brooks


April 28, 2017

The US Food and Drug Administration (FDA) has approved abaloparatide (Tymlos, Radius Health) subcutaneous injection for postmenopausal women with osteoporosis at high risk for fracture due to a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have not responded to or are intolerant to other available osteoporosis therapy, the company announced.

Abaloparatide is the first new anabolic treatment approved for postmenopausal women with osteoporosis in the United States in nearly 15 years, the company said.

The recommended dose is 80 μg administered subcutaneously once daily into the periumbilical region of the abdomen. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

The approval of abaloparatide was based on results at 18 months from the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and first 6 months of the ACTIVExtend trial.

In the ACTIVE trial of more than 2000 women, subcutaneous abaloparatide was associated with significant reductions in the relative risk for new vertebral fractures (86% reduction) and nonvertebral fractures (43% reduction) compared with placebo, as reported previously by Medscape Medical News.   The absolute risk reductions were 3.6% and 2.0%, respectively.

The benefits were evident regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and bone mineral density (BMD) at baseline.

In ACTIVExtend, as reported by Medscape Medical News, roughly 1100 patients who completed 18 months of abaloparatide or placebo in ACTIVE received open-label alendronate for up to 24 additional months. Data from the first 6 months of ACTIVExtend showed improved BMD and reduced fracture risk throughout the skeleton.  

The approval of abaloparatide "provides physicians a new treatment option for postmenopausal women with osteoporosis which could help to rapidly, consistently and significantly increase bone mineral density and reduce their risk of fractures," John Bilezikian, MD, director of the metabolic bone diseases program at Columbia University Medical Center in New York City, said in a company news 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," Dr Bilezikian said.

The label  for abaloparatide contains a boxed warning noting that the drug caused a dose-dependent increase in the incidence of osteosarcoma in rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80-μg dose. Whether abaloparatide will cause osteosarcoma in humans is unknown.

Use of abaloparatide is not recommended in patients at increased risk for osteosarcoma, including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external-beam or implant radiation therapy involving the skeleton, the label states.

Cumulative use of abaloparatide and other parathyroid hormone analogs (eg, teriparatide) for more than 2 years during a patient's lifetime is not recommended.

Abaloparatide will be available in the United States in June, the company said.

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