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

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...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news