Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY ™ (romosozumab)

Potential New Treatment Option for the Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture THOUSAND OAKS, Calif. and BRUSSELS, Jan. 16, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal Phase 3 studies. Eighteen of 19 members voted yes for approval. In their discussion, the Committee emphasized the need for po...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news