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,3 which included 7,180 postmenopausal women with osteoporosis, and BRIDGE,4 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 AABP. "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."
Read more: https://prn.to/2sky0LW