Amgen and UCB announced that an application seeking marketing approval of romosozumab for the treatment of osteoporosis for those at high risk of fracture has been submitted for review to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Amgen and UCB are co-developing romosozumab worldwide, with development in Japan being led by Amgen Astellas BioPharma (AABP) K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
Japan has one of the longest life expectancy rates in the world, and it is believed that the percentage of the population over 60 will be over 37 percent in 2050.1 As such, osteoporosis among the aging population in Japan is a major public health issue. Today, the prevalence of osteoporosis in the country is around 12 million and the hip fracture incidence rate in the oldest population (over 75) is increasing dramatically in both men and women.
"Submitting romosozumab for marketing approval in Japan is an important milestone in our global development program with UCB and our strategic alliance with Astellas Pharma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with regulatory authorities in Japan with a goal of filling a great unmet need for patients with osteoporosis at high risk of fracture.
Romosozumab is an investigational monoclonal antibody that works by binding and inhibiting the activity of the protein sclerostin, and as a result, has a dual effect, both increasing bone formation and decreasing bone resorption.
"Our collaborative, patient-led and science-driven approach is bringing much needed treatment options to people living at risk of fracture due to osteoporosis," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We look forward to working with our partners, Amgen and Astellas, as we pursue our goal of bringing this important new treatment to those people living at risk of fracture from osteoporosis worldwide."
The Japanese New Drug Application for marketing approval for romosozumab contains data from two pivotal Phase 3 studies: FRAME (the placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis) including 7,180 women with postmenopausal osteoporosis, and BRIDGE (the placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) including 245 men with osteoporosis.
In the U.S. and Canada, Amgen has completed submission of regulatory filings for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
