TOKYO (March 4, 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”) today announced the world-first launch of the humanized anti-sclerostin monoclonal antibody EVENITY® (generic name: romosozumab (Genetical Recombination) Injection) in Japan for the treatment of osteoporosis in patients with a high risk of fracture.1

Satoshi Soen M.D., Ph.D, professor at the Department of Orthopedic Surgery and Rheumatology, Kindai University Nara Hospital said, “EVENITY® not only increases bone formation, but also reduces bone resorption. Further, it inhibits cortical bone porosity. It demonstrates a significant increasing effect for bone mineral density at an early stage after administration, and a reduction in the incidence of vertebral fracture, non-vertebral fracture, and hip fracture has been confirmed. It is supported by the evidence from multiple clinical trials that EVENITY® can be a first-line treatment for patients with osteoporosis at high risk of fracture such as those with a prior vertebral fracture or those with a significant decrease in bone mineral density”.

Yukiya Suzuki, the Head of Sales of Amgen Astellas said, “Japan is becoming a super-aged society, and fractures caused by osteoporosis, which are expected to further increase, significantly affect not only healthy life expectancy but also life prognosis as they can result in care and assistance becoming necessary. Through its dual effect, EVENITY® significantly increases bone mineral density for a short period and also reduces the risk of fractures. We are very delighted to provide EVENITY® as a new therapeutic option to physicians and healthcare professionals in Japan.”

Nobuaki Tanaka, Senior Vice President, Sales & Marketing Japan of Astellas said, “Through the world-first launch of EVENITY®, we would like to address the unmet medical needs of Japanese patients with osteoporosis at high risk of fracture.”

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 will not be involved in product promotion for EVENITY®.

EVENITY® is jointly developed by Amgen Astellas and Astellas in Japan. 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.