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 novel bone-builder with a dual effect that increases bone formation and, to a lesser extent, reduces bone resorption (or bone loss).
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.
It will now be reviewed by the European Commission, which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 2019.
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."
Amgen and UCB are co-developing romosozumab.