Amgen and UCB have resubmitted the Biologics License Application for Evenity (romosozumab), an investigational treatment for osteoporosis in postmenopausal women at high risk for fracture.
Evenity is a bone-forming monoclonal antibody designed to inhibit the activity of sclerostin, which allows the drug to rapidly increase bone formation and reduce bone resorption simultaneously.
Last July, the Companies received a Complete Response Letter from the Food and Drug Administration (FDA), which requested the safety and efficacy data from the Phase 3 active-comparator ARCH study (N= 4093 postmenopausal women with osteoporosis who experienced a fracture) and the Phase 3 BRIDGE study (N=245 men with osteoporosis) be included in the resubmission.
The new BLA includes data from both of these trials in addition to data from the FRAME study (N=7180 postmenopausal women with osteoporosis). The FDA will now examine the benefit-risk profile of romosozumab, including the cardiovascular safety signal seen in the ARCH study.
This article originally appeared on MPR