The Japanese Ministry of Health, Labor and Welfare has granted a marketing authorisation for EVENITY (romosozumab; Amgen and UCB) 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 KK, a joint venture between Amgen and Astellas Pharma, headquartered in Tokyo.
The approval is based on results from two pivotal Phase 3 studies: FRAME, which included 7,180 postmenopausal women with osteoporosis, and BRIDGE, 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.
Japan has one of the longest life expectancy rates in the world, and it is believed that by 2050, over 37 percent of the population will be aged 60 or older. Age is one of the most common risk factors associated with developing osteoporosis, as bone mass is lost over time. Today, the prevalence of osteoporosis in the country is around 12 million, and the hip fracture incidence rate in the population over 75 is increasing dramatically in both men and women.
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.