FDA advisory committee to review Evenity to treat osteoporosis in postmenopausal women at high risk for fracture.-Amgen + UCB.

Amgen and UCB announced the FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review data supporting the Biologics License Application (BLA) for Evenity(romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on 16 January 2019.

The Evenity development program includes three pivotal Phase III studies that included more than 11,000 patients: FRAME,1 including 7,180 postmenopausal women with osteoporosis; ARCH,2 including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE,3 including 245 men with osteoporosis. The BRUDAC will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of Evenity, including the cardiovascular safety findings 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.

Comment: In July 2018 , Amgen and UCB resubmitted the BLA to the FDA for Evenity. Marketing authorization applications for Evenity are also ongoing in other parts of the world including Europe and Japan.