Radius Health, Inc.,a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, recently announced that the US Food and Drug Administration (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.

Clinical Data
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 mineral density (BMD), and to increase a marker of bone formation. In addition, the anabolic effect of 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.
About Tymlos (abaloparatide)
Tymlos (abaloparatide) was approved by the U.S. Food and Drug Administration or 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. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of women with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA).
Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis.

IMPORTANT SAFETY INFORMATION
Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown if Tymlos will cause osteosarcoma in humans.
The use of Tymlos is not recommended in patients at increased risk of 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. Cumulative use of Tymlos and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.

Orthostatic Hypotension: Orthostatic hypotension may occur with Tymlos, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary.
Hypercalcemia: Tymlos may cause hypercalcemia. Tymlos is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia.

Hypercalciuria and Urolithiasis: Tymlos may cause hypercalciuria. It is unknown whether Tymlos may exacerbate urolithiasis in patients with active or a history of urolithiasis. If active urolithiasis or pre-existing hypercalciuria is suspected, measurement of urinary calcium excretion should be considered.

INDICATIONS AND USAGE
Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a 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 fractures and nonvertebral fractures.

Source: Radius Health, Inc.