Amgen and UCB have secured Japanese approval for Evenity for treating osteoporosis in patients at high risk of fracture.
The two companies are jointly developing Evenity (romosozumab) globally, with development in Japan spearheaded by joint venture Amgen Astellas BioPharma.
“The approval of Evenity in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis,” said David M. Reese, Executive Vice President of Research and Development at Amgen.
“A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture.”
Evenity 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.
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.
To date, this is the first approval for Evenity in the world, and the third approval of a new medicine through AABP.
The US FDA and the European Medicines Agency are currently reviewing marketing applications for Evenity.