Monday, July 17, 2017
Amgen and UCB today announced that the U.S. 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."