Bezlotoxumab

Drug Profile

Bezlotoxumab

Alternative Names: CDB1; Clostridium difficile toxin B monoclonal antibody; MBL-CDB1; MDX-1388; MK 6072; Zinplava

Latest Information Update: 29 Dec 2016

Price : $50

At a glance

  • Originator Medarex; University of Massachusetts Medical School
  • Developer Merck & Co
  • Class Antidiarrhoeals; Monoclonal antibodies
  • Mechanism of Action Botulinum toxin inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Clostridium infections

Most Recent Events

  • 22 Nov 2016 Committee for Medicinal Products for Human Use (CHMP) of EMA recommends approval of bezlotoxumab for Clostridium infections (Prevention of relapse) in European Union
  • 21 Oct 2016 Registered for Clostridium infections (Prevention of relapse) in USA (IV) - First global approval
  • 21 Jul 2016 PDUFA action date extended by US FDA to 23/10/2016 for BLA for Clostridium infections (Prevention of relapse)
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