Golimumab

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Golimumab
Monoclonal antibody
Type Whole antibody
Source Human
Target TNFα
Clinical data
Trade names Simponi
AHFS/Drugs.com Monograph
MedlinePlus a610010
License data
Routes of
administration
Subcutaneous injection
Legal status
Legal status
Identifiers
CAS Number 476181-74-5 N
ATC code L04AB06 (WHO)
ChemSpider none
UNII 91X1KLU43E YesY
KEGG D04358 YesY
ChEMBL CHEMBL1201833 N
Chemical data
Formula C6530H10068N1752O2026S44
Molar mass 147 kg/mol
 NYesY (what is this?)  (verify)

Golimumab (CNTO 148)[1] is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[2] and hence is a TNF inhibitor.

Golimumab was developed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.[3]

Golimumab is approved in Canada[4] and the United States[5] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.[6][7] Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[8]

European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[9] Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[10]

Clinical trials[edit]

Rheumatoid arthritis[edit]

Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone.[11]

References[edit]

  1. ^ Mazumdar, Sohini; David Greenwald (2009). "Golimumab". mAbs 1 (5): 422–431. doi:10.4161/mabs.1.5.9286. 
  2. ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab, American Medical Association.
  3. ^ "SIMPONI® Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis | Johnson & Johnson". www.jnj.com. Retrieved 2016-05-09. 
  4. ^ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis".  Apr 2009
  5. ^ FDA Approves Simponi
  6. ^ "FDA clears potential blockbuster arthritis drug". North County Times (Lee Enterprises). Associated Press. 24 April 2009. Retrieved 23 October 2010. 
  7. ^ Maxwell, LJ; Zochling, J; Boonen, A; Singh, JA; Veras, MM; Tanjong Ghogomu, E; Benkhalti Jandu, M; Tugwell, P; Wells, GA (18 April 2015). "TNF-alpha inhibitors for ankylosing spondylitis.". The Cochrane database of systematic reviews 4: CD005468. PMID 25887212. 
  8. ^ Löwenberg, Mark; de Boer, Nanne KH; Hoentjen, Frank (2014-03-12). "Golimumab for the treatment of ulcerative colitis". Clinical and Experimental Gastroenterology 7: 53–59. doi:10.2147/CEG.S48741. ISSN 1178-7023. PMC 3958527. PMID 24648749. 
  9. ^ "Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis". www.drugs.com. Retrieved 2016-05-09. 
  10. ^ Johnson & Johnson Reports 2008 First-Quarter Results
  11. ^ Oldfield V, Plosker GL.[1].Biodrugs 2009;23(2):125-135. doi:10.2165/00063030-200923020-00005.