Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY (romosozumab)
The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients. Notable Phase 3 studies include FRAME, a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE, an active comparator-controlled study with 436 postmenopausal women with osteoporosis. The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.