Amgen and UCB announced that the Japanese Ministry of Health, Labor and Welfare has granted a marketing authorization for EVENITY (romosozumab) for the treatment of osteoporosis in patients at high risk of fracture. Amgen and UCB are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo. EVENITY is a bone forming agent that both increases bone formation and reduces bone resorption to increase bone mineral density (BMD) and reduce the risk of fracture.

The approval is based on results from two pivotal Phase 3 studies: FRAME, which included 7,180 postmenopausal women with osteoporosis, and BRIDGE,4 which included 245 men with osteoporosis. The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.