FDA Rejects Romosozumab Biologics License Application, Requests More Data

Romosozumab is being investigated to treat postmenopausal women with osteoporosis.

The FDA rejected the Biologics License Application (BLA) yesterday for romosozumab (Evenity) for the treatment of postmenopausal women with osteoporosis.

Romosozumab is an investigational bone-forming monoclonal antibody designed to inhibit the activity of sclerostin, which allows the drug to rapidly increase bone formation and reduce bone resorption simultaneously, according to a press release.

The BLA included data from the pivotal phase 3, placebo-controlled FRAME study. The FDA issued a Complete Response Letter requesting that safety and efficacy data from the phase 3 active-comparator ARCH study be integrated into the application.

“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,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit/risk profile of Evenity.”

The FDA also requested that the resubmission include safety and efficacy data from the BRIDGE study, which evaluated romosozumab in men with osteoporosis.

“The reality is that once a woman has a fragility fracture, she is 5 times more likely to suffer another within a year,” said Dr Pascale Richetta, head of bone and executive vice president of UCB. “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.

“With all 3 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.”