US regulators turn away Amgen/UCB’s bone drug Evenity

Amgen and UCB’s application to market bone-boosting drug Evenity as a treatment for postmenopausal women with osteoporosis has hit a setback, having been turned down by US regulators. The US Food and Drug Administration has issued a Complete Response Letter asking for new safety and efficacy data from the Phase III active-comparator ARCH study to be integrated into the drug’s submission, to build on that included in the original filing taken from the Phase III placebo-controlled FRAME study. The resubmission will also include the efficacy and safety data from the BRIDGE study, a Phase III trial assessing Evenity (romosozumab) in men with osteoporosis, which has also been requested by the FDA.