Amgen and UCB on Tuesday reported getting licence to market Evenity to treat patients with osteoporosis, who have high risk of fracture.
The Japanese Ministry of Health, Labor and Welfare granting Evenity in Japan is a significant milestone that reinforces Amgen’s commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis, said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
He explained that a patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment.
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, where one included 7,180 postmenopausal women with osteoporosis, and one had 245 men with osteoporosis.
Entering the Japanese market to treat osteoporosis is a long term investment, as Japan has one of the longest life expectancy rates in the world. Dr Pscale Rocheta points out that this means that the rate of osteoporosis will increase, leaving many people at high risk for fracture due to the condition. Dr. Pascale Richetta is head of bone and executive vice president, UCB. “We are proud that Evenity is now approved as a new treatment to help address this important public health issue and help people with their osteoporosis,” he said.
This is the first approval for Evenity in the world, and the third approval of a new medicine through AABP.
The U.S. 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, Amgen’s statement concluded.