Posted by Michael Wonder on 21 Dec 2022
Radius Health’s Tymlos (abaloparatide) receives US FDA approval as a treatment to increase bone density in men with osteoporosis at high risk for fracture
20 December 2022 - Radius Health today announced that the US FDA has approved Tymlos (abaloparatide), a parathyroid hormone related peptide [PTHrP(1-34)] analogue, 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 3 ATOM trial, which was a randomised, double-blind, placebo-controlled, 12-month multi-centre trial designed to evaluate the efficacy and safety of abaloparatide 80 micrograms in men with osteoporosis.
