Dibotermin alfa - Medtronic

Drug Profile

Dibotermin alfa - Medtronic

Alternative Names: Amplify™ rhBMP-2 Matrix; Bone morphogenetic protein-2 - Pfizer/Astellas; InductOs; INFUSE Bone Graft; PF-5208771; rhBMP 2 - Pfizer/Astellas; rhBMP-2/CPM; YM 484

Latest Information Update: 14 Oct 2016

Price : $50

At a glance

  • Originator Wyeth
  • Developer Medtronic Europe; Medtronic Sofamor Danek; Pfizer
  • Class Calcium regulators; Proteins
  • Mechanism of Action Osteogenesis stimulants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Fracture; Intervertebral disc degeneration
  • Phase II Postmenopausal osteoporosis; Pseudoarthrosis
  • No development reported Bone disorders
  • Discontinued Cancer

Most Recent Events

  • 01 Mar 2016 Phase-II clinical trials in Pseudoarthrosis (In children, In adolescents) in USA (Implant) (NCT02718131)
  • 22 Oct 2015 The Committee for Medicinal Products for Human Use (CHMP) recommends suspension of dibotermin alfa (InductOs™) in the EU due to manufacturing issues related to an absorbable sponge component
  • 10 Apr 2014 No development reported - Phase-III for Bone disorders in Japan (Implant)
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