EVENITY® (romosozumab) has received positive CHMP opinion for the treatment of severe postmenopausal osteoporosis who are at high risk of fracture.
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 Authorisation 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).
An issue that is far too often overlooked
Dr Pascale Richetta, head of bone and executive vice president, UCB, explained: “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% of women aged 67 or older remain undiagnosed and untreated following a fracture. This is why new treatment options are so important.”
“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.
“One step closer to becoming a new osteoporosis treatment option”
“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, MD, 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 US, 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.
About EVENITY® (romosozumab)
Romosozumab is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption.
The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing romosozumab to either placebo or active comparator in over 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis.
This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality