Amgen and UCB announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. 

EVENITY increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.

“A fracture due to osteoporosis can be a life-altering event, and EVENITY has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to continuing our work with the FDA to demonstrate the benefit:risk profile for EVENITY. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”

The BLA for EVENITY now adds results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis. The FDA will evaluate the clinical benefit:risk profile of EVENITY, including the cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk of fractures and increase BMD in postmenopausal women with osteoporosis. The original FDA submission included data from a comprehensive Phase 1 and Phase 2 program and the Phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis. 

“The burden of osteoporosis can have tremendous impact on a patient’s life,” said Pascale Richetta, M.D., head of bone and executive vice president at UCB. “We are one step closer in our ability to bring this first of its kind treatment to thousands of women affected by fragility fractures each year.”

The European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing.