The FDA has turned down an application from Amgen and UCB to approve romosozumab (tentatively branded as Evenity) as a treatment for postmenopausal women with osteoporosis.
Amgen said the agency has issued a complete response letter for the Evenity biologics license application (BLA) asking that efficacy and safety data from the ARCH study be integrated into the application. The original submission included data from the pivotal phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis, but data from the phase 3 active-comparator ARCH study is now available.
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 the FDA has also requested. This request will be addressed in the form of a resubmission, which Amgen said 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, MD, executive vice president of Research and Development at Amgen.
When all three pivotal romosozumab phase 3 studies are included in the clinical evidence package, the data will represent more than 11,000 patients.
Romosozumab is an investigational bone-forming monoclonal antibody.
Source: Amgen; July 16, 2017.