Amgen and UCB announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CLR) for the Biologics License Application (BLA) for Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis.
Data from the Phase 3 placebo-controlled FRAME study were included in the the original BLA submission but the FDA has requested that the safety and efficacy data from the Phase 3 active-comparator ARCH study and the Phase 3 BRIDGE study also be included in the resubmission.
Evenity, an investigational bone-forming monoclonal antibody, is intended to inhibit sclerostin. This mechanism allows Evenity to quickly increase bone formation and decrease bone resorption at the same time.
Dr. Pascale Richetta, head of bone and executive vice president, UCB, stated, “With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures.”