Romosozumab met both primary endpoints in the ARCH phase 3 study of postmenopausal women with osteoporosis, according to a company release.
“The efficacy results from this study comparing Evenity [(Romosuzomab, UCB and Amgen)] to an active control are robust,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data.”
In the ARCH study, women received subcutaneous injections of romosozumab — which increases bone formation and reduces bone resorption — every month for 12 months and then then took oral alendronate every week for 12 months.
After 24 months, women in the romosozumab treatment group showed a 50% reduction in relative risk of spinal fracture compared with alendronate treatment alone. Women in the romosozumab group also had a 27% reduction in risk for clinical fracture as well as a 19% reduced risk for non-vertebral fracture. Adverse events were similar between treatment groups; however, there was a 2.5% incidence of cardiovascular events after 12 months for the romosozumab compared with a 1.9% incidence for alendronate.
“We are working on understanding the observed cardiovascular safety signal and will continue to discuss these results with global regulators and experts in the field,” Iris Loew-Friedrich, chief medical officer of UCB, said in the release.