8 January 2018 - Application supported by Phase 3 data in more than 11,000 post-menopausal women and men with osteoporosis at increased risk of fracture.

Amgen and UCB today announced that the EMA has accepted the marketing authorisation application for Evenity (romosozumab) for the treatment of osteoporosis in post-menopausal women and in men at increased risk of fracture. If approved in Europe, Evenity will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.

The application for Evenity is based on results from three pivotal Phase 3 studies: FRAME, including 7,180 post-menopausal women with osteoporosis; ARCH, including 4,093 post-menopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis. The agency will evaluate the clinical benefit:risk profile of Evenity in these three pivotal studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study.

Read Amgen press release