ARCH study: Romosozumab data show increased cardiovascular risk

Treatment with the anti-sclerostin monoclonal antibody romosozumab resulted in fewer new fractures in postmenopausal women with high-risk osteoporosis compared with alendronate, according to a press release from Amgen.

However, romosozumab (Evenity, Amgen and UCB) resulted in more cardiovascular serious adverse events (2.5%) compared with alendronate (1.9%) at 12 months, according to the release.

In the ARCH study, 4,093 participants were assigned to receive a subcutaneous injection of romosozumab monthly for 12 months followed by alendronate for at least 12 months or alendronate alone. At 24 months, romosozumab followed by alendronate resulted in a 50% reduction in relative risk for new vertebral spine fracture, a 27% reduction in the relative risk for clinical fracture and a 19% reduced risk for nonvertebral fractures compared with alendronate alone.

“The efficacy results from this study comparing Evenity to an active control are robust,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “At the same time, the newly observed CV safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity. Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data.”

Overall, adverse events were relatively similar between the two groups.

“We are working on understanding the observed CV safety signal and will continue to discuss these results with global regulators and experts in the field,” Iris Loew-Friedrich, UCB’s chief medical officer, said in the release.

Evenity is currently under FDA review based on results of the FRAME study.

“Amgen has agreed with the FDA that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization, and as a result the company does not expect approval of Evenity in the U.S. to occur in 2017,” according to the release.