Amgen and UCB’s Evenity approved in Japan for osteoporosis

pharmafile | January 9, 2019 | News story | Research and Development, Sales and Marketing Amgen, Japan, UCB Pharma, osteoporosis, pharma 

Amgen has revealed that its bone-forming monoclonal antibody Evenity (romosozumab), developed in partnership with UCB Pharma, has been awarded approval in Japan for the treatment of osteoporosis in patients at high risk of fracture.

The decision, which precedes final verdicts in the US and Europe, where review is currently ongoing, was based on Phase 3 data from two studies encompassing 7,180 postmenopausal women and 245 men with osteoporosis, finding the drug to be both safe and effective following a robust review.

Under the established partnership, the Tokyo-headquartered joint venture between Amgen and Astellas known as Amgen Astellas BioPharma KK (AABP) led development of the drug in the country. The drug works by increasing bone formation and decreasing bone resorption, bolstering bone mineral density (BMD) and minimising the risk of fracture.

“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, Amgen’s Executive Vice President of Research and Development. “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.”

Steve Sugino, Amgen’s Vice President and President and Representative Director of AABP, also remarked: “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. 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.”

Age is one of the foremost risk factors in developing osteoporosis, and with over 37% of the Japanese population forecast to be 60 years old or older by 2050, the approval could prove a crucial one in the coming years. The condition already affects around 12 million in the country today.

Matt Fellows

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