FDA approves Evenity to treat osteoporosis in postmenopausal women at high risk for fracture
Amgen and UCB announced that the FDA has approved Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Evenity is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption (or bone loss) to rapidly reduce the risk of fracture. A full course of Evenity therapy is 12 monthly doses administered by a healthcare provider. Since osteoporosis is a chronic disease, continued therapy with an anti-resorptive agent should be considered once Evenity therapy is complete.
The FDA based its approval of Evenity on the results of two Phase III studies. In the placebo-controlled FRAME study, treatment with Evenity resulted in a significant reduction of new vertebral (spine) fracture at 12 months compared to placebo. This significant reduction in fracture risk persisted through the second year in women who received Evenity during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, Evenity significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from Evenity to denosumab at month 12, BMD continued to increase through month 24.
In the active-controlled ARCH study, treatment with Evenity for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. Evenity followed by alendronate significantly reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. Evenity significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with Evenity followed by 12 months of treatment with alendronate significantly increased BMD compared with alendronate alone.