=Amgen (AMGN): results from the Phase 3 ARCH study

Amgen announces results from the Phase 3 ARCH study

Amgen (AMGN) and UCB announced detailed results from the Phase 3 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 results were simultaneously published in the New England Journal of Medicine (NEJM) and presented today as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Denver.
• 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.
• An imbalance in adjudicated cardiovascular serious adverse events was observed during the 12-month period in 50 patients treated with alendronate, with cardiac ischemic events and cerebrovascular events accounting for the imbalance.
• There were six patients with positively adjudicated events of atypical femoral fracture during the open-label alendronate period, two patients treated with EVENITY followed by alendronate and four treated with alendronate alone.
• "The ARCH study shows that romosozumab can provide superior fracture risk reduction over alendronate, a commonly used, first-line osteoporosis treatment."