Amgen And UCB Provide Update On Regulatory Status Of EVENITY ™ (romosozumab) In The US

THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the Phase 3 active-comparator ARCH study, the Agency has asked that the efficacy and safety data from the study be integrated into the application. The resubmission will a...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news