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Reuters reports that FDA approval of romosozumab (brand name Evenity) may be held up because of higher rates of cardiac events seen in a late-stage clinical trial.
Romosozumab is being codeveloped by Amgen and UCB who have released top-line results of the ARCH trial, a successful study in postmenopausal women with osteoporosis (OP).
Patients in the study received romosozumab for 12 months followed by alendronate, versus those on alendronate alone. Romosozumab was shown to significantly reduce vertebral and non-vertebral fractures through 24 months compared to alendronate.
However, an imbalance of serious heart problems were reported; 2.5 percent on romosozumab versus 1.9 in the alendronate group. Interestingly, no increased risk of cardiac events was seen in another pivotal trial, the placebo-controlled FRAME study (n=7180-patients). The company reports that other adverse events were equal between groups.
"The efficacy results from this study comparing Evenity to an active control are robust. At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit/risk profile for Evenity," Amgen research chief Sean Harper said.
These findings are thought to create significant obstacles for bringing this drug to market in 2017.