Amgen has received a Complete Response Letter for the Biologics License Application from the FDA asking the company to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application for romosozumab as a treatment for postmenopausal women with osteoporosis, according to a company press release.
The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) conducted in nearly 7,200 women. Integrated into the application will be data from the ARCH study, which showed a 50% reduction in the relative risk for spinal fracture, a 19% reduced risk for nonvertebral fracture and a 72% reduced risk for clinical fracture in postmenopasaul women treated with romosozumab (EVENITY). A 2.5% incidence of cardiovascular events after 12 months was reported. Safety and efficacy data from the BRIDGE study, which evaluated romosozumab in men with osteoporosis, will also be included.
“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. “We look forward to working through the review process with the agency. We remain committed to helping patients with osteoporosis and will use the additional time to better understand the benefit:risk profile.”
“The reality is that once a woman has a fragility fracture, she is five times more likely to suffer another within a year,” Pascale Richetta, MD, head of bone and executive vice president at UCB, said in the release. “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 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.”