US FDA panel recommends romosozumab for osteoporosisMarch 7, 2019
The US FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) recommended the approval of romosozumab (Evenity) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Eighteen of 19 members voted in favour of the approval yes for approval, Amgen and UCB announced.
Romosozumab is an investigational bone-forming monoclonal antibody that inhibits the activity of sclerostin. This enables romosozumab to rapidly increase bone formation and reduce bone resorption simultaneously.
The romosozumab development programme 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 and risk profile of romosozumab.