Golimumab

Drug Profile

Golimumab

Alternative Names: Anti-TNF-alpha monoclonal antibody - Centocor/Medarex; CNTO-148; Simponi; Simponi Aria; Simponi I.V

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Centocor; Medarex
  • Developer Centocor; Centocor Ortho Biotech; Janssen Biotech; Janssen Pharmaceutical KK; Merck & Co; Mitsubishi Tanabe Pharma Corporation
  • Class Anti-inflammatories; Anti-TNF monoclonal antibodies; Antirheumatics
  • Mechanism of Action Immunomodulators; Tumour necrosis factor alpha inhibitors
  • Orphan Drug Status

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

    Yes - Sarcoidosis
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Ankylosing spondylitis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Preregistration Juvenile rheumatoid arthritis
  • Phase I/II Hearing disorders
  • Phase I Type 1 diabetes mellitus
  • Discontinued Asthma; Cardiovascular disorders; Sarcoidosis; Uveitis

Most Recent Events

  • 28 Feb 2017 Merck has patent protection for golimumab (Simponi®) in Europe (Merck Annual report 2016)
  • 20 Dec 2016 Preregistration for Psoriatic arthritis and Ankylosing spondylitis (Treatment-experienced) in USA (IV)
  • 30 Nov 2016 Janssen completes the phase III GO-ALIVE trial in Ankylosing Spondylitis (Treatment-experienced) in USA and Germany (IV) (NCT02186873; EudraCT2014-000241-74)
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