Posted by Michael Wonder on 13 Jul 2018
Amgen and UCB resubmit biologics license application for Evenity (romosozumab) to the US FDA
12 July 2018 - Application includes data from pivotal Phase 3 studies of more than 11,000 patients.
Amgen and UCB today announced the resubmission of the biologics license application to the U.S. FDA for Evenity (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in post-menopausal 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.
The application for Evenity now adds results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 post-menopausal 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 post-menopausal 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 post-menopausal women with osteoporosis.
