The European Medicines Agency has accepted UCB and Amgen’s submission seeking approval for use of bone-boosting drug Evenity in post-menopausal women and in men at increased risk of fracture.
If approved, Evenity (romosozumab) will offer patients a novel option that increases bone formation while reducing bone resorption to boost bone mineral density and reduce the risk of fracture.
The filing includes data from three pivotal Phase III studies: FRAME including 7,180 postmenopausal women with osteoporosis; ARCH including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE including 245 men with osteoporosis, which highlighted the drug’s potential in this setting.
For example, women receiving once-monthly subcutaneous injections of Evenity in the FRAME trial experienced a 73 percent reduction in the relative risk of a vertebral fracture through 12 months compared to those receiving placebo, and this effect persisted after transitioning to treatment with denosumab through the second year.
“We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture,” said Dr Pascale Richetta, head of bone and executive vice president, UCB.
“Without adequate management, some fragility fractures may lead to a loss of autonomy in patients’ daily lives,” she added, and noted that the firm is “striving to help patients avoid potentially debilitating fractures and to help close this concerning gap.”
Evenity’s path to approval in the US suffered a set back in July last year when regulators 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 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 in men with osteoporosis, which has also been requested by the FDA.