Ibalizumab - TaiMed Biologics

Drug Profile

Ibalizumab - TaiMed Biologics

Alternative Names: 5AB; Hu1A8; Hu5A8; Ibalizumab-uiyk; Monoclonal antibody 5A8; TMB-355; TNX-355; Trogarzo

Latest Information Update: 22 Aug 2018

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At a glance

  • Originator Biogen Idec
  • Developer TaiMed Biologics; Theratechnologies
  • Class Antiretrovirals; Monoclonal antibodies
  • Mechanism of Action HIV fusion 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

  • Marketed HIV-1 infections

Most Recent Events

  • 20 Aug 2018 Paediatric Committee of the European Medicines Agency defers the initiation of Paediatric Investigation Plan for Human immunodeficiency virus type 1 (HIV-1) infection
  • 20 Aug 2018 Theratechnologies announces intention to launch ibalizumab in the Europe
  • 31 Jul 2018 Preregistration for HIV-1 infections in European Union before July 2018 (IV)
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