Amgen, UCB say FDA to review EVENITY
Amgen and UCB announced the U.S. Food and Drug Administration Bone, Reproductive and Urologic Drugs Advisory Committee, or BRUDAC, will review data supporting the Biologics License Application for EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on Jan. 16, 2019. "After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a potential new bone forming therapy that has been shown to reduce their risk of fracture within the first year," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing the efficacy and safety data from our EVENITY clinical program with the members of the Committee." "We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated 77 percent of women aged 67 or older remaining undiagnosed and untreated in the first six months after a fracture.4 This is a stark reminder of the need to improve post-fracture care and reduce the risk of future fractures," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We believe EVENITY has the potential to help postmenopausal women with osteoporosis who are at high risk for fracture, and we look forward to the interactions with the members of the Committee."