The application comprises all indications covered by Amgen’s reference medicines, Prolia and Xgeva, including osteoporosis in postmenopausal women and in men at an increased risk of fractures.
In the US alone, more than ten million adults over the age of 50 are estimated to have osteoporosis, a condition that weakens bones, making them fragile and more likely to break.
Postmenopausal women are disproportionately impacted by the condition and account for around 80% of the estimated US osteoporosis patient population, with one in two of these women predicted to have an osteoporosis-related fracture in their lifetimes.
