Thousand Oaks biotech giant Amgen is seeking marketing approval in Japan for osteoporosis drug romosozumab, the company announced on Dec. 20.
Amgen submitted the request to the Pharmaceuticals and Medical Devices Agency in Japan, where an estimated 12 million people have a high risk of bone fracture. The company is co-developing the drug worldwide with Euronext Brussels: UCB, with development in Japan being led by Amgen Astellas BioPharma 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 the percentage of the population over 60 will be more than 37 percent in 2050, Amgen said.
“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 Dr. Sean Harper, Amgen executive vice president of research and development.
The request for romosozumab contains data from two Phase 3 studies: the placebo-controlled fracture study in postmenopausal women with osteoporosis including 7,180 women with postmenopausal osteoporosis and the placebo-controlled study evaluating the efficacy and safety of the drug for men with osteoporosis including 245 men with osteoporosis.
In the U.S. and Canada, Amgen has submitted regulatory filings for the drug’s treatment of osteoporosis in postmenopausal women with increased risk of fracture.
Romosozumab is an investigational monoclonal antibody that works by binding and inhibiting the activity of the protein sclerostin. It increases bone formation and decreases bone resorption, Amgen said.
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