Therapy Areas: Cardiovascular
Amgen submits EVENITY's MAA with EMA for the treatment of osteoporosis in women and men
8 January 2018 -

Human therapeutics company Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels:UCB) on Friday reported the filing of Marketing Authorisation Application (MAA) for EVENITY with the European Medicines Agency (EMA) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

Osteoporosis is a condition that weakens bone over time, making them thinner, more brittle and more likely to break. The patients who experience an osteoporotic fracture are twice as likely to suffer a future fracture, yet approximately 80% of patients are not treated for underlying osteoporosis after a fracture.

The company said the EVENITY (romosozumab) is an investigational bone-forming monoclonal antibody and is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to increase bone formation and reduce bone resorption simultaneously.

Upon approval 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.

EVENITY's MAA is based on results from the company's three pivotal 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.

In conjunction, the EMA agency will evaluate the clinical benefit:risk profile of EVENITY in these three pivotal 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, concluded the company.

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