July 17, 2017
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.