UCB and Amgen have brought their bone-boosting drug Evenity back to US regulators for review, following an initial rejection in July last year.
The companies are seeking permission to market Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
The US Food and Drug Administration had 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, as well as efficacy and safety data from the BRIDGE study, which tested Evenity in men with osteoporosis.
The resubmission now contains extra data from both these trials, the firms said.
Evenity is an investigational bone-forming monoclonal antibody designed to inhibit the protein sclerostin. It has a dual effect on bone, increasing bone formation and decreasing bone resorption.
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.
The relative risk of a clinical fracture (non-vertebral and vertebral) through 12 months was reduced by 36 percent compared to patients taking a receiving placebo.
The ARCH study found that through 24 months, postmenopausal women with osteoporosis in the Evenity treatment group experienced a statistically significant 48 percent relative reduction in the risk of a new vertebral (spine) fracture compared with those receiving alendronate alone (6.2 percent versus 11.9 percent, respectively).
Also, women taking Evenity experienced a statistically significant 27 percent relative reduction in the risk of clinical fracture, which includes non-vertebral fracture and clinical vertebral fracture (9.7 percent versus 13.0 percent, respectively).
“A fracture due to osteoporosis can be a life-altering event, and romosozumab has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” said Sean Harper, executive vice president of Research and Development at Amgen.
“We look forward to continuing our work with the FDA to demonstrate the benefit-risk profile for romosozumab. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”
Evenity is also currently under review in Europe.