Amgen and UCB Provide Regulatory Update on Status of EVENITY romosozumab in the EU

Amgen and UCB Provide Regulatory Update on Status of EVENITY™ (romosozumab) in the EU

00:59 EDT 28 Jun 2019 | AMGEN

THOUSAND OAKS, Calif. and BRUSSELS, June 27, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP. "After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,1 and these fractures can be life-changing. Yet these patients often remain undiagn...

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