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Siltuximab - EUSA Pharma/Janssen Biotech

Drug Profile

Siltuximab - EUSA Pharma/Janssen Biotech

Alternative Names: Anti-interleukin-6 monoclonal antibody - Centocor; cCLB8; Chimeric anti-interleukin-6 monoclonal antibody - Centocor; CNTO-328; Sylvant

Latest Information Update: 12 Jul 2020

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At a glance

  • Originator Janssen Biotech
  • Developer Centocor; EUSA Pharma; Janssen Biotech; Memorial Sloan-Kettering Cancer Center; Papa Giovanni XXIII Hospital
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Interleukin 6 inhibitors
  • Orphan Drug Status

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

    Yes - Giant lymph node hyperplasia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Giant lymph node hyperplasia
  • Phase II Multiple myeloma
  • Clinical Phase Unknown Adult respiratory distress syndrome
  • No development reported Paraproteinaemia
  • Discontinued Myelodysplastic syndromes; Non-Hodgkin's lymphoma; Prostate cancer; Renal cell carcinoma

Most Recent Events

  • 02 Nov 2020 EUSA Pharma plans a phase III trial in Adult respiratory distress syndrome (Combination therapy) (associated with COVID-2019 infections) in USA (IV) (NCT04616586)
  • 02 Jul 2020 The US FDA approves a clinical trial application for a phase III trial in Adult respiratory distress syndrome (Combination therapy) (associated with COVID-2019 infections) (IV)
  • 11 May 2020 EUSA Phrama plans to submit BLA to NMPA in China in 2020
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