Amgen and UCB announce positive romosozumab results
pharmafile | February 22, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Amgen, Romosozumab, UCB, osteoporosis
Romosozumab development partners Amgen and UCB have announced positive top-line results from a Phase III study of the drug in postmenopausal women with osteoporosis.
The companies say the FRAME study met all its primary endpoints, by reducing the incidence of new vertebral fracture through 12 and 24 months. The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months.
An additional secondary endpoint of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met, the companies added.
In FRAME, women given monthly romosozumab injections experienced a 73% reduction in the relative risk of a spine fracture through 12 months, compared to those in the placebo group. The effect size persisted after both groups were transitioned to denosumab through the second year of treatment.
“A vertebral fracture due to osteoporosis can be a life-altering event, and the risk of these kinds of fractures will be a growing burden as our society ages,” says Sean Harper, executive vice president of Research and Development at Amgen. “These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months.”
Professor Dr Iris Loew-Friedrich, chief medical officer and executive vice president, UCB, adds: “These data are encouraging and in meeting the co-primary endpoints of this study, romosozumab has shown to be effective in reducing the incidence of new vertebral fractures at months 12 and 24 and for clinical fractures as early as 12 months. Deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis.”
UCB and Amgen say they will discuss the FRAME study’s findings with a view to possibly submitting romosozumab to global regulators later this year.
Amgen partnered with Celltech to develop the drug back in 2002, and the latter company was acquired by UCB two years later. Phase III trials began recruiting in 2014.
Joel Levy
Related Content
FDA accepts UCB’s sBLA for Bimzelx
UCB has announced that the US Food and Drug Administration (FDA) has accepted for review …
Amgen opens new biomanufacturing facility in Ohio, US
Amgen has announced that it has opened a new manufacturing site in Central Ohio, US. …
Rani Therapeutics’ oral ‘robotic pill’ delivers injection trans-enterically
US Rani Therapeutics, a clinical-stage biotherapeutics company, has reported new results from its phase 1 …
