Ibalizumab

Drug Profile

Ibalizumab

Alternative Names: 5AB; Hu5A8; Monoclonal antibody 5A8; TMB-355; TNX-355

Latest Information Update: 23 Mar 2017

Price : $50

At a glance

  • Originator Biogen Idec
  • Developer TaiMed Biologics
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action CD4 antigen inhibitors; HIV fusion inhibitors; Virus internalisation inhibitors
  • Orphan Drug Status

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

    Yes - HIV-1 infections
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III HIV-1 infections

Most Recent Events

  • 06 Mar 2017 Theratechnologies acquires commercial rights to ibalizumab from TaiMed Biologics in European Union, Israel, Norway, Russia and Switzerland
  • 06 Mar 2017 Theratechnologies announces intention to initiate discussion to submit a MAA with the EMA
  • 23 Feb 2017 TaiMed Biologics announces intention to submit BLA to the US FDA in March 2017
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