Radius Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TYMLOS® (abaloparatide), a parathyroid hormone related peptide [PTHrP(1-34)] analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy. This approval is based on the Phase 3 ATOM study ("Abaloparatide Treatment of Men; BA058-05-019"), which was a randomized, double-blind, placebo-controlled, 12-month multicenter study designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis. The primary efficacy endpoint of the ATOM study was the % change from baseline in bone mineral density (BMD) at the lumbar spine at 12 months, which was 8.5% and 1.2% in abaloparatide and placebo groups, respectively.

This treatment difference between abaloparatide and placebo was 7.3% (99% CI: 5.1%, 9.6%; p<0.0001). Osteoporosis-related fractures are an important health concern because of related morbidity, mortality, and cost. Bruce Mitlak, M.D., the Chief Medical Officer of Radius, emphasized that "30% of all hip fractures occur in men and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture.

Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality." TYMLOS was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, based on the Phase 3 ACTIVE study.1 Abaloparatide met the primary efficacy endpoint with a statistically significant relative risk reduction of new vertebral fracture at Month 18 versus placebo (0.6% versus 4.2%, respectively, p<0.0001). There was an 86% relative risk reduction in new vertebral fractures in postmenopausal women receiving abaloparatide versus placebo. The most common adverse reactions (incidence =2%) reported with TYMLOS in men with osteoporosis are injection site erythema (13%), dizziness (9%), arthralgia (7%), injection site swelling (7%), injection site pain (6%), contusion (3%), abdominal distention (3%), diarrhea (3%), nausea (3%), abdominal pain (2%), and bone pain (2%).

The most common adverse reactions (incidence =2%) reported with TYMLOS in postmenopausal women with osteoporosis are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%), palpitations (5%), fatigue (3%), upper abdominal pain (3%), and vertigo (2%).