EVENITY® (romosozumab) Approved to Reduce the Risk of Fractures and Increase Bone Mineral Density in Postmenopausal Women and Men With Osteoporosis
TOKYO (January 9, 2019) - Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”), Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), and UCB Japan (Headquarters, Tokyo; President: Kanako Kikuchi, “UCB Japan”) announced that the Japanese Ministry of Health, Labor and Welfare has granted the world-first marketing authorization for humanized anti-sclerostin monoclonal antibody EVENITY® (generic name: romosozumab (Genetical Recombination) Injection) for the treatment of osteoporosis in patients at high risk of fracture which is jointly developed by Amgen Astellas and Astellas. 1
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: FRAME2, which included 7,180 postmenopausal women with osteoporosis and BRIDGE3, 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.
In Japan osteoporotic fracture is one of the leading causes for patients losing independence and needing nursing care. As the aged population of Japan increases, preventing such fractures should be given high priority,” said Steve Sugino, Amgen vice president and president and representative director of Amgen Astellas. “Japanese patients will be the first in the world to have a new therapeutic option for osteoporosis that reduces the risk of fracture by not only increasing bone formation but also decreasing bone resorption.” 4
“Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent,” said Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university’s Fujii Memorial Institute of Medical Sciences. “Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan.”
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. 5 Age is one of the most common risk factors associated with developing osteoporosis, as bone mass is lost over time. 6 7 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. 8
“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, M.D., 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. 9 With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture.”
This is the first approval for EVENITY in the world, and the third approval of a new medicine through Amgen Astellas.
Amgen Astellas and Astellas will co-promote EVENITY. Based on an agreement between UCB and Amgen, UCB Japan is responsible for a disease state approach to raise awareness, understanding and treatment rates for patients with osteoporosis in Japan. UCB Japan’s disease state efforts will not involve Evenity’s product promotion.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently reviewing marketing authorization applications for EVENITY and interactions with the agencies are ongoing.
This was publicly announced in the United States on January 8, 2019 PST.