Romosozumab to treat osteoporosisJune 11, 2019
Amgen and UCB announced that the US FDA has approved romosozumab-aqqg (Evenity) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
Romosozumab-aqqg has a dual effect that both increases bone formation and to a lesser extent reduces bone resorption. A full course of the therapy is 12 monthly doses.
The FDA based its approval of romosozumab-aqqg on the results of two phase 3 studies. In the placebo-controlled FRAME study, treatment with romosozumab-aqqg resulted in a significant reduction of new vertebral fracture at 12 months compared to placebo. This significant reduction in fracture risk persisted through the second year in women who received the drug during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab.
In addition, romosozumab-aqqg significantly increased bone mineral density at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from romosozumab-aqqg to denosumab at month 12, BMD continued to increase through month 24.
In the active-controlled ARCH study, treatment with romosozumab-aqqg for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months.