Radius Health announced FDA approval of TYMLOS (abaloparatide) to increase bone density in men with osteoporosis at high risk for fracture, expanding the drug beyond its original April 2017 approval for postmenopausal women. The approval was based on the Phase 3 ATOM study (BA058-05-019), a 12-month randomized, double-blind trial in 228 men. Lumbar spine BMD rose 8.5% with abaloparatide versus 1.2% with placebo, a 7.3% difference (p<0.0001).
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