Evenity (romosozumab) ARCH phase III study meets primary and key secondary endpoints in osteoporosis- Amgen/UCB

Amgen and UCB announced that the Evenity (romosozumab) ARCH phase III study met both primary endpoints and the key secondary endpoint in osteoporosis. At the primary analysis, treatment with Evenity for 12 months followed by alendronate significantly reduced the incidence of new vertebral fractures through 24 months, clinical fractures (primary endpoints) and non-vertebral fractures (key secondary endpoint) in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone. An imbalance in positively adjudicated cardiovascular serious adverse events was observed as a new safety signal (2.5 percent Evenity versus 1.9 percent alendronate at 12 months).

In this study, women received subcutaneous injection of Evenity monthly for 12 months followed by oral alendronate weekly for at least 12 months. At 24 months, women in the Evenity treatment group experienced a statistically significant 50 percent reduction in the relative risk of a new vertebral (spine) fracture compared to those receiving alendronate alone. Women in the Evenity treatment group also experienced a statistically significant 27 percent reduction in the relative risk of clinical fracture (non-vertebral fracture and clinical vertebral fracture) at the primary analysis.

Additionally, non-vertebral fractures were statistically significantly reduced by 19 percent in the Evenity treatment group, including a nominally significant reduction in hip fractures. Overall adverse events and serious adverse events were generally similar between the treatment groups throughout the study and also in the initial 12-month Evenity treatment period. In the initial 12-month Evenity treatment period, the three most commonly reported adverse events in both arms were nasopharyngitis, back pain and arthralgia.