Sep 262013

SIMPONI® , golimumab

First and Only Subcutaneous Biologic Treatment Administered Every Four Weeks Approved for Ulcerative Colitis

LEIDEN, The Netherlands, Sept. 23, 2013 /PRNewswire/ — Janssen Biologics B.V. (“Janssen”) announced today that the European Commission has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.  The European Commission approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2013 recommending the use of SIMPONI.

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Golimumab (Simponi; Centocor Ortho Biotech), a fully human antibody that is specific for tumour necrosis factor, was approved by the US FDA for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in April 2009.

Golimumab is a human immunoglobulin G1 mAb that is specific for human TNF2, 3, 4, 5. It was created using genetically engineered mice that were immunized with human TNF, resulting in an antibody with human-derived variable and constant regions4, 5. Golimumab binds to both the soluble and transmembrane bioactive forms of human TNF, preventing the binding of TNF to its receptors and thereby inhibiting the biological activity of TNF

In the past decade, the introduction of biologics that inhibit the activity of the pro-inflammatory cytokine tumour necrosis factor (TNF) has revolutionized the treatment of a range of immuno-inflammatory disorders, such as rheumatoid arthritis, psoriasis and Crohn’s disease1. The first two such biologics — infliximab (Remicade; Centocor/Schering-Plough), a chimeric monoclonal antibody (mAb) specific for TNF, and etanercept (Enbrel; Amgen/Wyeth), a fusion protein that contains the ligand-binding portion of the soluble TNF receptor — were approved for the treatment of rheumatoid arthritis in the late 1990s. Their use has since been expanded to other disorders, including psoriatic arthritis. In 2002, the fully human TNF-specific mAb adalimumab (Humira; Abbott) was approved for the treatment of rheumatoid arthritis and is now also approved for several other immuno-inflammatory disorders. A fourth TNF inhibitor, the PEGylated humanized TNF-specific antibody fragment certolizumab pegol (Cimzia; UCB), was approved for Crohn’s disease in 2008 and rheumatoid arthritis in May 2009.

Golimumab, in combination with MTX, is approved by the FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis. It is also approved for the treatment of adult patients with active psoriatic arthritis (alone or in combination with MTX) and for the treatment of adult patients with active ankylosing spondylitis




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