A new treatment for severe osteoporosis has received a positive opinion recommending marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
Romosozumab (Evenity) 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 CHMP’s recommendation came after a re-examination procedure and is for postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. A European Commission decision is expected by year-end 2019.
The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. Romosozumab has been studied for its potential to reduce the risk of fractures in an extensive global phase 3 programme 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.
Dr Pascale Richetta, head of bone and executive vice president, UCB, said: “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. 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.”
David M. Reese, executive vice president of Research and Development at Amgen, added: “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."