Phase III ARCH study results with Evenity (romosozumab) for osteoporosis published in The New England Journal Of Medicine.- Amgen/UCB.

Amgen and UCB announced detailed results from the Phase III ARCH study showing that 12 months of Evenity (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone. Overall adverse events and serious adverse events were generally similar between the treatment groups with the exception of the previously reported imbalance in positively adjudicated cardiovascular serious adverse events. The study found that through 24 months, postmenopausal women with osteoporosis in the Evenity treatment group experienced a statistically significant 48.0 percent relative reduction in the risk of a new vertebral (spine) fracture compared with those receiving alendronate alone (6.2 percent versus 11.9 percent, respectively.

At primary analysis, women in the Evenity treatment group also experienced a statistically significant 27.0 percent relative reduction in the risk of clinical fracture, which includes non-vertebral fracture and clinical vertebral fracture (9.7 percent versus 13.0 percent, respectively. At primary analysis, postmenopausal women in the Evenity treatment group experienced a statistically significant 19.0 percent relative reduction in the risk of non-vertebral fractures (8.7 percent versus 10.6 percent, respectively). A 38.0 percent relative reduction in the risk of hip fractures was also observed (2.0 percent versus 3.2 percent, respectively), when compared to those receiving alendronate alone. Overall, adverse events and serious adverse events were generally similar between the treatment groups.

The results were simultaneously published in the New England Journal of Medicine (NEJM) and presented as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research.

See: Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.