Amgen and UCB said Monday that a late-stage study of the experimental drug romosozumab in postmenopausal women with osteoporosis met all of its primary endpoints by reducing the incidence of new vertebral fractures through months 12 and 24. The companies indicated that they plan to discuss the results with global regulators in anticipation of a potential filing in 2016.
The FRAME trial randomised 7180 postmenopausal women with osteoporosis to receive either romosozumab or placebo for 12 months. After this period, all patients received Amgen's Prolia (denosumab) every six months for 12 months. The study evaluated the effectiveness of romosozumab versus placebo in reducing the risk of new vertebral fractures through 12 months. The trial also looked to see if treatment with romosozumab followed by Prolia, compared with placebo followed by Prolia, was effective in reducing the risk of new vertebral fractures through 24 months.
Amgen and UCB noted that as well as meeting its main goals, top-line results showed that the study met the secondary endpoint of reducing the incidence of clinical fractures in postmenopausal women with osteoporosis through 12 months. However, the secondary goal of reducing the incidence of non-vertebral fractures through months 12 and 24 was not met.
Specifically, results showed that women who received romosozumab experienced a significant 73 percent reduction in the relative risk of a vertebral fractures through 12 months compared to those given placebo. Amgen and UCB said that the effect size persisted after both groups were transitioned to Prolia, with data indicating that women treated with romosozumab followed by Prolia had a significant 75 percent reduction in the relative risk of new vertebral fractures through month 24 compared to those who received placebo followed by Prolia. In addition, patients receiving romosozumab experienced a significant 36 percent reduction in the relative risk of a clinical fractures through 12 months compared to those administered placebo.
"These data are encouraging," remarked Iris Loew-Friedrich, UCB's chief medical officer, adding "deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis." Last year, Amgen and UCB announced that romosozumab met the primary endpoint of a Phase III study in women with postmenopausal osteoporosis versus Eli Lilly's Forteo (teriparatide), with the experimental drug demonstrating a significant difference in the percent change of total hip bone mineral density through month 12 (for related analysis, see ViewPoints: Amgen, UCB’s romosozumab hits in first Phase III but key fracture data still to come).
Analyst predict that if approved, romosozumab could generate sales of $1 billion or more split evenly between Amgen and UCB.
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