Brussels, Belgium and Thousand Oaks, Calif. (October 18, 2019 - 07:00)
UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending Marketing Authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. Romosozumab is a novel bone-builder with a dual effect that increases bone formation and, to a lesser extent, reduces bone resorption (or bone loss).
“Post-menopausal osteoporosis and fragility fractures are a significant women’s health issue that’s far too often overlooked, with evidence showing that an estimated 77 percent of women aged 67 or older remain undiagnosed and untreated following a fracture. This is why new treatment options are so important,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We believe that the Committee’s positive opinion is an important step forward to help improve the lives of post-menopausal women with severe osteoporosis who are at high risk of fragility fractures.”
The CHMP’s recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 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,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are pleased by the Committee’s opinion, which brings romosozumab one step closer to becoming a new osteoporosis treatment option for patients with severe osteoporosis at high risk of fracture in Europe.”
Romosozumab is approved in U.S, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Romosozumab is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture, in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.