New Osteoporosis Treatment Approved by the FDA
The US Food and Drug Administration has approved Tymlos (abaloparatide) for the treatment of postmenopausal women with osteoporosis with a high risk for fracture or who were not responsive or unable to take other osteoporosis therapy. Tymlos is administered as an injection, and reduces the risk of vertebral and nonvertebral fractures.
The safety and efficacy of Tymlos was demonstrated in an 18-month randomized, placebo controlled trial and a 6-month extension of the same trial that included 2463 women with osteoporosis randomly assigned to received either 80 mcg of abaloparatide-SC or placebo. Women who received Tymlos had an 86% reduction in the relative risk of new vertebral fractures and 43% relative risk reduction in nonvertebral fractures compared with participants who received placebo. The absolute risk reductions were 3.6% and 2%, respectively.
Common adverse events associated with Tymlos include vertigo, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and hypercalciuria.
Patients with an increased risk of osteosarcoma are not recommended to receive Tymlos as the drug was associated with a dose-dependent increased incident of osteosarcoma in rats. Whether Tymlos increases the incidents of osteosarcoma in humans is still unknown.
FDA approves radius health's Tymlos (abaloparatide), a bone building agent for the treatment of postmenopausal women with osteoporosis at high risk for fracture [press release]. Waltham, MA: Radius; April 28, 2017. http://investors.radiuspharm.com/releasedetail.cfm?ReleaseID=1023557.