TOKYO (Dec. 20, 2016) – Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; General Manager and Representative Director: Mark Tennyson, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Yoshihiko Hatanaka, “Astellas”) announced that Amgen Astellas submitted an application seeking marketing approval of romosozumab (AMG785) for the treatment of osteoporosis for those at high risk of fracture for review to the Ministry of Health, Labour and Welfare in Japan. Amgen Astellas and Astellas are co-developing romosozumab in Japan.
Osteoporosis is a major public health issue in Japan. It is estimated that nearly 9.8 million women and three million men aged 40 or older have osteoporosis.1 Fractures associated with the condition may lead to impairment in mobility and interfere with activities of daily living.1
Romosozumab is an investigational monoclonal antibody that works by binding and inhibiting the activity of sclerostin, a glycoprotein secreted by osteocytes in bone, thereby increasing bone formation and decreasing bone resorption.
The Japanese New Drug Application for marketing approval for romosozumab contains data from two pivotal Phase 3 studies: the placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME) including 7,180 women with postmenopausal osteoporosis, and the placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn (BRIDGE) with osteoporosis including 245 men with osteoporosis.
In the U.S. and Canada, Amgen has submitted regulatory filings for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.