Research & Development
Amgen & UCB partnership wins marketing authorisation in Japan for EVENITY to treat osteoporosis
9 January 2019 -

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) disclosed on Tuesday the receipt of the Japanese Ministry of Health, Labor and Welfare's marketing authorisation for EVENITY for the treatment of osteoporosis in patients at high risk of fracture in Japan, which has one of the longest life expectancy rates in the world.

The company said EVENITY (romosozumab) 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. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to both rapidly increase bone formation and reduce bone resorption simultaneously. Age is one of the most common risk factors associated with developing osteoporosis, as bone mass is lost over time.

Under the partnership, the companies are co-developing EVENITY worldwide, with development in Japan being led by Amgen Astellas BioPharma KK, a joint venture between Amgen and Astellas Pharma Inc, headquartered in Tokyo.

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

Also, the company said this is the first approval for EVENITY in the world and the third approval of a new medicine through AABP. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing, said the companies.



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