FDA Alerts

FDA approves abaloparatide for osteoporosis in men

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The U.S. Food and Drug Administration has approved abaloparatide (Tymlos) 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, according to a press release.

Approval is based on the Phase 3 ATOM study which evaluated the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis. The primary efficacy endpoint was the percent change from baseline in bone mineral density 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%.

“Tymlos has been helping postmenopausal women with osteoporosis at high risk for fracture for over five years. We are excited that with this approval, we can bring TYMLOS to a new population,” said Chhaya Shah, Chief Business Officer at Radius in the press release. “We are grateful to the men who participated in the ATOM study, as they played a pivotal role in helping bring this important treatment to men with osteoporosis at high risk of fracture.”

Read the full press release here.