Amgen Inc.'s osteoporosis drug Evenity (romosozumab) is likely headed toward approval with the drugmaker's proposed indication following a favorable vote from the US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, although the type of postmarketing study the agency will require to assess cardiovascular risk remains unclear following disagreements among the panelists.
At a Jan. 16 meeting, 15 committee members voted to recommend approval for Evenity for the treatment of osteoporosis in postmenopausal women at high risk of fracture