Romosozumab - UCB

Drug Profile

Romosozumab - UCB

Alternative Names: AMG-785; Anti-sclerostin; Anti-sclerostin monoclonal antibody; CDP-7851; EVENITY; Sclerostin Ab

Latest Information Update: 13 Sep 2017

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At a glance

  • Originator UCB
  • Developer Amgen; UCB
  • Class Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action SOST protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Male osteoporosis; Postmenopausal osteoporosis
  • Discontinued Fracture

Most Recent Events

  • 11 Sep 2017 Efficacy data from the phase III ARCH trial in Postmenopausal osteoporosis presented at the 39th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR-2017)
  • 16 Jul 2017 Amgen receives complete response letter from the FDA for romosozumab in postmenopausal osteoporosis
  • 29 Jun 2017 Amgen completes a phase II trial in Postmenopausal osteoporosis in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, the Czech Republic, Colombia, Denmark, Dominican Republic, Estonia, Finland, France, Greece, Germany, Guatemala, Hong Kong, Hungary, Italy, Ireland, Israel, Lithuania, Mexico, New Zealand, Poland, Peru, South Korea, Romania, Russia, Latvia, Netherlands, Norway, Spain, Slovakia, South Africa, Sweden, Taiwan, Turkey, the United Kingdom and the USA (NCT01631214)
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