U.S. FDA Accepts Biologics License Application for Romosozumab, Amgen and UCB Announce


Sept. 26, 2016

Amgen and UCB have announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab. It is an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and hindering the activity of the protein sclerostin, naturally occurring in the bone, thereby reducing bone resorption and increasing bone formation.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “We believe romosozumab could serve as an important therapeutic option for osteoporosis patients with an increased risk of fracture. We look forward to potentially providing a new therapy to address a critical unmet medical need and further supporting patients worldwide.”

The BLA was submitted on July 19, 2016. It was based on data from the pivotal Phase 3 placebo-controlled fracture study in postmenopausal women with osteoporosis (FRAME) in almost 7,200 patients.

“Once a patient suffers a fragility fracture, the burden of osteoporosis can have a tremendous impact on a patient’s life. We are pleased with the FDA’s acceptance of the BLA filing for review and hope to continue the regulatory process towards U.S. approval to introduce a potential therapy to reduce the risk of fractures for this patient population,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB.


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