Golimumab: Difference between revisions
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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> |
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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> |
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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. |
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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
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 |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
ChemSpider | |
UNII | |
KEGG | |
ChEMBL | |
ECHA InfoCard | 100.226.360 |
Chemical and physical data | |
Formula | C6530H10068N1752O2026S44 |
Molar mass | 147 kDa g·mol−1 |
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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
- ^ "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.
- ^ 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) - ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab, American Medical Association.
- ^ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis". Apr 2009
- ^ FDA Approves Simponi
- ^ "FDA clears potential blockbuster arthritis drug". North County Times. Lee Enterprises. Associated Press. 24 April 2009. Retrieved 23 October 2010.
- ^ Johnson & Johnson Reports 2008 First-Quarter Results
- ^ FDA approves Johnson & Johnson rheumatoid arthritis drug golimumab
- ^ [1] Merck sees fast ruling in J&J Remicade arbitration
- ^ "Simponi European Public Assessment Report". European Medicines Agency. Retrieved 2009-11-15.
- ^ Oldfield V, Plosker GL.[2].Biodrugs 2009;23(2):125-135. doi:10.2165/00063030-200923020-00005.