The FDA approved a new indication for the use of the osteoporosis medicine, Prolia® (denosumab): “Treatment to increase bone mass in men with osteoporosis at high risk for fracture.”
With this approval five osteoporosis medicines are approved for use in men: Fosamax® (alendronate), Actonel® (risedronate), Reclast® (zoledronic acid), Forteo® (teriparatide), and Prolia® (denosumab).
On the heels of the European Union’s approval, the FDA announced today approval of Amgen’s osteoporosis drug Prolia™ (denosumab) for treatment of postmenopausal women with osteoporosis. We were expecting news later in the summer, so this early announcement was a surprise. Prolia™ is given in your doctor’s office as a shot under the skin twice… Read more
Prolia™ (denosumab), a medicine for treatment of osteoporosis under review by the FDA, received approval today (May 28, 2010) for marketing in the European Union. For Amgen, the maker of Prolia™, this was the drug’s first approval for use. The approval was 2-fold: 1- for treatment of osteoporosis in postmenopausal women at increased risk of fractures… Read more