Amgen and UCB has announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.

The original submission included data from the pivotal phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the phase 3 active-comparator ARCH study, the Agency has asked that the efficacy and safety data from the study be integrated into the application. The resubmission will also include the efficacy and safety data from the BRIDGE study, the phase 3 trial evaluating Evenity in men with osteoporosis, which has also been requested. This request will be addressed in the form of a resubmission, which is an extension of the current review.

"During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request. We look forward to working through the review process with the Agency," said Sean E. Harper, M.D., executive vice president of research and development at Amgen. "We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit: risk profile of Evenity."

"The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year. This is a stark reminder that there is an urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in the future," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "With all three pivotal romosozumab phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures."

Evenity is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables Evenity to rapidly increase bone formation and reduce bone resorption simultaneously. Evenity has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing Evenity to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing Evenity.