New Romosozumab BLA Includes Data from Additional Osteoporosis Trials
Evenity is a bone-forming monoclonal antibody designed to inhibit the activity of sclerostin
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.