Amgen and UCB's Evenity study, which analyzed the drug as a treatment for postmenopausal women with osteoporosis, met both primary and secondary endpoints.
"The efficacy results from this study comparing Evenity to an active control are robust," Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement. "At the same time, the newly observed cardiovascular 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."
Patients in the study given Evenity for 12 months followed by alendronate saw reductions in vertebral fracture incidents through 24 months as well as reductions in clinical fractures and non-vertebral fractures when compared to patients treated solely with alendronate.
"We are impressed with the statistically significant superior fracture risk reduction of EVENITY over alendronate, a current standard of care in osteoporosis," Dr. Iris Loew-Friedrich, UCB's chief medical officer, said. "When we think that patients who have had a fracture are highly likely to suffer another one, the importance of post-fracture care cannot be emphasized enough. 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."