FDA accepts for review BLA application for romosozumab as a treatment of osteoporosis in postmenopausal women at increased risk of fracture.- Amgen + UCB

Amgen and UCB announced that the FDA has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

The BLA, submitted on 19 July 2016, is based on data from the pivotal Phase III placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 19 July, 2017, for romosozumab.