• The US FDA has approved Tymlos for the treatment of men with osteoporosis who are at high risk of fracture, who have failed or are intolerant to other available osteoporosis therapy
• The approval was based on the P-III study (ATOM) evaluating abaloparatide (80ug) vs PBO in a ratio (2:1) in 228 patients with osteoporosis. The 1EPs of the study was the percent change from baseline in bone mineral density at the lumbar spine (8.5% vs 1.2%) @12mos., treatment difference was 7.3% while the 2EPs incl. the percent change from baseline in BMD at the total hip & femoral neck @12mos.
• Tymlos has been approved in the US in April 2017, based on the P-III study (ACTIVE) for postmenopausal women with osteoporosis

Ref: PRNewswire | Image: Radius Health