Drug Profile


Alternative Names: 16C4-aFuc; A-fucosylated anti-CD19 antibody; Anti-CD19 MAb; MEDI 551

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Cellective Therapeutics
  • Developer MedImmune
  • Class Antineoplastics; Eye disorder therapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action CD19 antigen inhibitors
  • Orphan Drug Status

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

    Yes - Neuromyelitis optica
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II/III Neuromyelitis optica
  • Phase II Chronic lymphocytic leukaemia
  • Phase I/II B cell lymphoma; Multiple sclerosis
  • Phase I Systemic scleroderma
  • Phase 0 Multiple myeloma
  • Discontinued Diffuse large B cell lymphoma

Most Recent Events

  • 17 Jul 2017 MedImmune plans a phase II trial for Multiple myeloma (Newly diagnosed, Second-line therapy or greater) in USA (NCT03218163)
  • 29 Mar 2017 Inebilizumab receives Orphan Drug status for Neuromyelitis optica in European Union
  • 01 Sep 2016 Discontinued - Phase-II for Diffuse large B cell lymphoma (Combination therapy, Second-line therapy or greater, Treatment-resistant) in Turkey, Spain, Russia, Poland, Israel, Hungary, Germany, France, Czech Republic, Canada, USA (IV) prior to September 2016 due to unfavourable safety and efficacy results (AstraZeneca pipeline, November 2016; Third quarter results, November 2016)
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