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Golimumab was developed by [[Centocor]] and is approved in Canada<ref>{{cite web |url=http://www.centocororthobiotech.com/cobi/viewDocumentByTitleAlias.html?title=PR_SIMPONI_CANADIAN_APPROVAL |title=Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis |format= |work= |accessdate=}} Apr 2009</ref>
Golimumab was developed by [[Centocor]] and is approved in Canada<ref>{{cite web |url=http://www.centocororthobiotech.com/cobi/viewDocumentByTitleAlias.html?title=PR_SIMPONI_CANADIAN_APPROVAL |title=Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis |format= |work= |accessdate=}} Apr 2009</ref>
and the United States<ref>[http://www.drugs.com/newdrugs/simponi-golimumab-receives-fda-approval-first-once-monthly-anti-tnf-rheumatoid-arthritis-psoriatic-1329.html FDA Approves Simponi]</ref>
and the United States<ref>[http://www.drugs.com/newdrugs/simponi-golimumab-receives-fda-approval-first-once-monthly-anti-tnf-rheumatoid-arthritis-psoriatic-1329.html FDA Approves Simponi]</ref>
as a once monthly subcutaneous treatment for adults with moderately to severely active [[rheumatoid arthritis]], [[psoriatic arthritis]], and [[ankylosing spondylitis]].<ref name="ap">{{cite news |url=http://www.nctimes.com/business/article_95a13fa4-8492-5080-8ee0-bbce644fb21b.html |title=FDA clears potential blockbuster arthritis drug |work=[[North County Times]]|publisher=[[Lee Enterprises]] |agency=[[Associated Press]] |date=24 April 2009|accessdate=23 October 2010}}</ref> Golimumab has been approved in 2013 for use in adults with moderately to severely active Crohn's or Ulcerative Colitis.
as a once monthly subcutaneous treatment for adults with moderately to severely active [[rheumatoid arthritis]], [[psoriatic arthritis]], and [[ankylosing spondylitis]].<ref name="ap">{{cite news |url=http://www.nctimes.com/business/article_95a13fa4-8492-5080-8ee0-bbce644fb21b.html |title=FDA clears potential blockbuster arthritis drug |work=[[North County Times]]|publisher=[[Lee Enterprises]] |agency=[[Associated Press]] |date=24 April 2009|accessdate=23 October 2010}}</ref> Golimumab has been approved in 2013 for use in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis.


In the same year, [[Johnson & Johnson]], the parent company of Centocor, also received [http://insciences.org/article.php?article_id=7069 an approval] from [[European Medicines Agency]] (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.<ref>[http://sev.prnewswire.com/retail/20080415/NYTU07615042008-1.html Johnson & Johnson Reports 2008 First-Quarter Results]</ref> Golimumab is marketed by [[Merck & Co, Inc.]] in Europe, pending final arbitration between J&J and Merck.<ref>[http://www.latimes.com/business/la-fi-arthritis25-2009apr25,0,1270502.story FDA approves Johnson & Johnson rheumatoid arthritis drug golimumab]</ref><ref>[http://www.reuters.com/article/idUSN0722206120100907] Merck sees fast ruling in J&J Remicade arbitration
In the same year, [[Johnson & Johnson]], the parent company of Centocor, also received [http://insciences.org/article.php?article_id=7069 an approval] from [[European Medicines Agency]] (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.<ref>[http://sev.prnewswire.com/retail/20080415/NYTU07615042008-1.html Johnson & Johnson Reports 2008 First-Quarter Results]</ref> Golimumab is marketed by [[Merck & Co, Inc.]] in Europe, pending final arbitration between J&J and Merck.<ref>[http://www.latimes.com/business/la-fi-arthritis25-2009apr25,0,1270502.story FDA approves Johnson & Johnson rheumatoid arthritis drug golimumab]</ref><ref>[http://www.reuters.com/article/idUSN0722206120100907] Merck sees fast ruling in J&J Remicade arbitration

Revision as of 14:58, 22 January 2014

Golimumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTNFα
Clinical data
Trade namesSimponi
AHFS/Drugs.comMonograph
MedlinePlusa610010
License data
Routes of
administration		Subcutaneous injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
UNII
KEGG
ChEMBL
ECHA InfoCard100.226.360 Edit this at Wikidata
Chemical and physical data
FormulaC6530H10068N1752O2026S44
Molar mass147 kDa g·mol−1
 ☒NcheckY (what is this?)  (verify)

Golimumab (CNTO 148)[2] 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[3] and hence is a TNF inhibitor.

Golimumab was developed by Centocor and 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] Golimumab has been approved in 2013 for use in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis.

In the same year, Johnson & Johnson, the parent company of Centocor, also received an approval from European Medicines Agency (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[7] Golimumab is marketed by Merck & Co, Inc. in Europe, pending final arbitration between J&J and Merck.[8][9] [10]

Efficacy

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

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ Mazumdar, Sohini (2009). "Golimumab". mAbs. 1 (5): 422–431. doi:10.4161/mabs.1.5.9286. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  3. ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab, American Medical Association.
  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. ^ Johnson & Johnson Reports 2008 First-Quarter Results
  8. ^ FDA approves Johnson & Johnson rheumatoid arthritis drug golimumab
  9. ^ [1] Merck sees fast ruling in J&J Remicade arbitration
  10. ^ "Simponi European Public Assessment Report". European Medicines Agency. Retrieved 2009-11-15.
  11. ^ Oldfield V, Plosker GL.[2].Biodrugs 2009;23(2):125-135. doi:10.2165/00063030-200923020-00005.
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