FDA approves Tymlos for men with osteoporosis.- Radius Health
Radius Health announced that the 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 III ATOM study ("Abaloparatide Treatment of Men; BA058-05-019")(previously cited), 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 percent 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).></0.0001).>
The most common adverse reactions (incidence at least 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%).
Tymlos was approved in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, based on the Phase III ACTIVE study. 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.></0.0001).>
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