Biotechnology company Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) on Thursday jointly filed the Biologics License Application (BLA) of EVENITY (romosozumab) with the US Food and Drug Administration (FDA) for treating osteoporosis in postmenopausal women at high risk for fracture.

According to the companies, EVENITY is an investigational bone-forming monoclonal antibody and is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously.

Since 2004, the companies have been working together to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis.

The EVENITY's BLA is based on the 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.

In conjunction with the submission, the US 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, said the company.

Additionally, the partnership's original US FDA submission included data from a comprehensive Phase 1 and Phase 2 programme,the Phase 3 placebo-controlled FRAME study as well as the 7,180 postmenopausal women with osteoporosis.