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Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA

01:01 EDT 13 Jul 2018 | AMGEN

BLA Includes Data From Pivotal Phase 3 Studies of More Than 11,000 Patients THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal 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. "A fracture due to osteoporosis can be a life-altering event, and EVENITY...

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