11 January 2018 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) and Brussels, Belgium-based biopharmaceutical company UCB's (Euronext Brussels: UCB) marketing authorization application (MAA) for Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture has been accepted by the European Medicines Agency (EMA), the company said.
If approved in Europe, Evenity will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.
The MAA for Evenity is based on results from three Phase 3 studies: FRAME, including 7,180 postmenopausal women with osteoporosis; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis.
The agency will evaluate the clinical benefit:risk profile of Evenity in these three studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study.
Evenity is an investigational bone-forming monoclonal antibody designed to work by inhibiting the activity of sclerostin, which enables Evenity to increase bone formation and reduce bone resorption simultaneously.
The global Phase 3 program includes two large fracture trials comparing Evenity to either placebo or active comparator in more than 11,000 postmenopausal women with osteoporosis.
Amgen and UCB are co-developing Evenity.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.
UCB is focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of EUR 4.2bn in 2016.