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Ustekinumab

January 01, 1970

Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[12] targeting both IL-12 and IL-23.[13]

Ustekinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-12 and IL-23
Clinical data
Trade namesStelara
Other namesCNTO 1275
Biosimilarsustekinumab-aekn,[1] ustekinumab-auub,[2] Selarsdi,[1] Uzpruvo,[3] Wezlana[2][4]
AHFS/Drugs.comMonograph
MedlinePlusa611013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismunknown[8]
Elimination half-life15–32 days (average 3 weeks)[8]
Identifiers
CAS Number
  • 815610-63-0 N
DrugBank
  • DB05679 Y
ChemSpider
  • none
UNII
  • FU77B4U5Z0
KEGG
  • D09214 Y
ChEMBL
  • ChEMBL1201835 N
Chemical and physical data
FormulaC6482H10004N1712O2016S46
Molar mass145648.06 g·mol−1
 NY (what is this?)  (verify)

Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union, and ulcerative colitis in the US, and in the EU to people who have not responded to more traditional treatments.[9][10][14][15] It was found not effective for multiple sclerosis.[16]

It is administered either by intravenous infusion or subcutaneous injection.[12] The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.[17]

Medical uses edit

Ustekinumab is used to treat psoriasis.[9] This includes psoriatic arthritis when it affects the skin.[12][9] It is indicated for the treatment of adult and adolescent patients (12 years and older) with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, and adults with active psoriatic arthritis (PsA) alone or in combination with methotrexate.[9][18] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.[9]

In the European Union, ustekinumab is approved to treat moderate to severe plaque psoriasis in adults and children above the age of six years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A);[10] active psoriatic arthritis in adults;[10] moderately to severely active Crohn's disease in adults;[10] and moderately to severely active ulcerative colitis in adults.[10]

Adverse effects edit

According to information provided by Centocor, maker of one medication based on ustekinumab, their version of ustekinumab is associated with several types of serious adverse effects. These include an increased risk of infection, such as by tuberculosis and an increased risk of certain types of cancer. As with some other immunosuppressant drugs like ciclosporin, the brain swelling of posterior reversible encephalopathy syndrome is a risk. The pharmaceutical company also reports serious allergic reaction as a possible side effect. More common side effects are upper respiratory infection, headache, and tiredness.[19]

Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.[20]

Pregnancy edit

It is unknown if the medication is safe during pregnancy or breastfeeding.[8]

Mechanism of action edit

Ustekinumab is designed to interfere with the triggering of the body's inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL-12 and IL-23 which help activate certain T-cells. It binds to the p-40 subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors.[21]

History edit

As of January 2007, there were five NIH-listed research studies involving CNTO 1275 on a multinational basis, including three phase II and two phase III trials. Three studies were focused on patients with psoriasis, one on psoriatic arthritis, and one on multiple sclerosis.[citation needed]

On December 4, 2007, a Biologic License Application (BLA) with the US Food and Drug Administration (FDA) was filed by Centocor and Janssen-Cilag International (collaborator) submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). On November 21, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies.[10][22]

Society and culture edit

Legal status edit

Since 2009, ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.[23] On September 24, 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.[citation needed]

On December 12, 2008, Health Canada approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.[24]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.[25][26]

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease.[27]

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.[28]

In 2019, the European Commission approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[14][10]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[29][30]

Biosimilars edit

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States.[2]

In November 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uzpruvo, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis,[31] psoriatic arthritis and Crohn's disease in adults.[31] The applicant for this medicinal product is STADA Arzneimittel AG.[31] Uzpruvo is a biosimilar medicinal product.[31] Uzpruvo was approved for medical use in the European Union in January 2024.[3][11]

In February 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.[32] The applicant for this medicinal product is Samsung Bioepis NL B.V.[32] Pyzchiva is a biosimilar medicinal product. Pyzchiva is a biosimilar medicinal product.[32]

Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024.[1]

In April 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.[33] The applicant for this medicinal product is Amgen Technology (Ireland) UC.[33]

References edit

  1. ^ a b c "Alvotech and Teva Announce U.S. FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)" (Press release). Alvotech. April 16, 2024. from the original on April 17, 2024. Retrieved April 17, 2024 – via GlobeNewswire.
  2. ^ a b c "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases". U.S. Food and Drug Administration (Press release). October 31, 2023. from the original on November 13, 2023. Retrieved November 13, 2023.   This article incorporates text from this source, which is in the public domain.
  3. ^ a b c "Uzpruvo EPAR". European Medicines Agency. November 9, 2023. from the original on January 9, 2024. Retrieved January 14, 2024.
  4. ^ a b c "Wezlana APMDS". Therapeutic Goods Administration (TGA). January 30, 2024. from the original on February 8, 2024. Retrieved March 7, 2024.
  5. ^ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. November 26, 2019. from the original on May 22, 2020. Retrieved April 6, 2020.
  6. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). June 21, 2022. from the original on March 31, 2024. Retrieved March 31, 2024.
  7. ^ "Regulatory Decision Summary for Wezlana/Wezlana I.V." Drug and Health Products Portal. December 27, 2023. from the original on April 2, 2024. Retrieved April 2, 2024.
  8. ^ a b c d "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). February 27, 2020. from the original on April 6, 2020. Retrieved April 6, 2020.
  9. ^ a b c d e f "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". DailyMed. March 24, 2020. from the original on July 2, 2019. Retrieved April 6, 2020.
  10. ^ a b c d e f g h "Stelara EPAR". European Medicines Agency (EMA). September 17, 2018. from the original on April 6, 2020. Retrieved April 6, 2020.
  11. ^ a b "Uzpruvo Product information". Union Register of medicinal products. January 8, 2024. from the original on January 10, 2024. Retrieved January 14, 2024.
  12. ^ a b c "Ustekinumab". The American Society of Health-System Pharmacists. from the original on February 2, 2017. Retrieved January 8, 2017.
  13. ^ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC 2726595. PMID 20069753.
  14. ^ a b "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. from the original on September 9, 2019. Retrieved September 26, 2019.
  15. ^ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. October 26, 2017. from the original on April 18, 2019. Retrieved October 4, 2019.
  16. ^ Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH (September 2008). "Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study". The Lancet. Neurology. 7 (9): 796–804. doi:10.1016/S1474-4422(08)70173-X. PMID 18703004. S2CID 20290673.
  17. ^ Reddy M, Davis C, Wong J, Marsters P, Pendley C, Prabhakar U (May 2007). "Modulation of CLA, IL-12R, CD40L, and IL-2Ralpha expression and inhibition of IL-12- and IL-23-induced cytokine secretion by CNTO 1275". Cellular Immunology. 247 (1): 1–11. doi:10.1016/j.cellimm.2007.06.006. PMID 17761156.
  18. ^ Toussirot E (April 2012). "The IL23/Th17 pathway as a therapeutic target in chronic inflammatory diseases". Inflammation & Allergy - Drug Targets. 11 (2): 159–168. doi:10.2174/187152812800392805. PMID 22280236.
  19. ^ "Important Safety Information". Stelara (ustekinumab). Janssen Biotech. May 22, 2019. from the original on March 29, 2021. Retrieved December 31, 2010.
  20. ^ Weber J, Keam SJ (2009). "Ustekinumab". BioDrugs. 23 (1): 53–61. doi:10.2165/00063030-200923010-00006. PMID 19344192. S2CID 265771199.
  21. ^ Koutruba N, Emer J, Lebwohl M (April 2010). "Review of ustekinumab, an interleukin-12 and interleukin-23 inhibitor used for the treatment of plaque psoriasis". Therapeutics and Clinical Risk Management. 6: 123–141. doi:10.2147/tcrm.s5599. PMC 2857612. PMID 20421912.
  22. ^ "FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application". Drugs.com (Press release). Centocor. September 25, 2009. from the original on April 6, 2020. Retrieved April 6, 2020.
  23. ^ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". from the original on August 1, 2013. Retrieved December 16, 2008.
  24. ^ "drugbank.ca". from the original on January 31, 2020. Retrieved October 4, 2019.
  25. ^ "Stelara approved for moderate to severe psoriasis. Sept 2009". September 26, 2009. from the original on September 20, 2015. Retrieved July 6, 2010.
  26. ^ "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". U.S. Food and Drug Administration (FDA). December 24, 1999. from the original on April 6, 2020. Retrieved April 6, 2020.
  27. ^ "Stelara (ustekinumab) Injection NDA #761044". U.S. Food and Drug Administration (FDA). January 12, 2018. from the original on April 6, 2020. Retrieved April 6, 2020.
  28. ^ "12 Sept 2017". from the original on March 15, 2021. Retrieved October 4, 2019.
  29. ^ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". FDA News. from the original on January 13, 2020. Retrieved October 31, 2019.
  30. ^ "Stelara: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). from the original on October 20, 2020. Retrieved April 6, 2020.
  31. ^ a b c d "Uzpruvo: Pending EC decision". European Medicines Agency (EMA). November 10, 2023. from the original on November 10, 2023. Retrieved November 13, 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  32. ^ a b c "Pyzchiva EPAR". European Medicines Agency. February 22, 2024. from the original on February 23, 2024. Retrieved February 23, 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  33. ^ a b "Wezenla EPAR". European Medicines Agency. April 25, 2024. from the original on April 30, 2024. Retrieved April 27, 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

January 01, 1970
ustekinumab, sold, under, brand, name, stelara, among, others, monoclonal, antibody, medication, developed, janssen, pharmaceuticals, treatment, crohn, disease, ulcerative, colitis, plaque, psoriasis, psoriatic, arthritis, targeting, both, monoclonal, antibody. Ustekinumab sold under the brand name Stelara among others is a monoclonal antibody medication developed by Janssen Pharmaceuticals for the treatment of Crohn s disease ulcerative colitis plaque psoriasis and psoriatic arthritis 12 targeting both IL 12 and IL 23 13 UstekinumabMonoclonal antibodyTypeWhole antibodySourceHumanTargetIL 12 and IL 23Clinical dataTrade namesStelaraOther namesCNTO 1275Biosimilarsustekinumab aekn 1 ustekinumab auub 2 Selarsdi 1 Uzpruvo 3 Wezlana 2 4 AHFS Drugs comMonographMedlinePlusa611013License dataUS DailyMed UstekinumabPregnancycategoryAU B1 5 4 Routes ofadministrationSubcutaneous intravenousATC codeL04AC05 WHO Legal statusLegal statusAU S4 Prescription only 4 6 CA only Schedule D 7 UK POM Prescription only 8 US only 9 EU Rx only 10 3 11 In general Prescription only Pharmacokinetic dataMetabolismunknown 8 Elimination half life15 32 days average 3 weeks 8 IdentifiersCAS Number815610 63 0 NDrugBankDB05679 YChemSpidernoneUNIIFU77B4U5Z0KEGGD09214 YChEMBLChEMBL1201835 NChemical and physical dataFormulaC 6482H 10004N 1712O 2016S 46Molar mass145648 06 g mol 1 N Y what is this verify Ustekinumab is approved to treat Crohn s disease in the United States Israel Australia and the European Union and ulcerative colitis in the US and in the EU to people who have not responded to more traditional treatments 9 10 14 15 It was found not effective for multiple sclerosis 16 It is administered either by intravenous infusion or subcutaneous injection 12 The antibody targets a subunit of human interleukin 12 and interleukin 23 which are naturally occurring proteins that regulate the immune system and immune mediated inflammatory disorders 17 Contents 1 Medical uses 2 Adverse effects 2 1 Pregnancy 3 Mechanism of action 4 History 5 Society and culture 5 1 Legal status 5 1 1 Biosimilars 6 ReferencesMedical uses editUstekinumab is used to treat psoriasis 9 This includes psoriatic arthritis when it affects the skin 12 9 It is indicated for the treatment of adult and adolescent patients 12 years and older with moderate to severe plaque psoriasis Ps who are candidates for phototherapy or systemic therapy and adults with active psoriatic arthritis PsA alone or in combination with methotrexate 9 18 It is also used to treat moderately to severely active Crohn s disease and moderately to severely active ulcerative colitis 9 In the European Union ustekinumab is approved to treat moderate to severe plaque psoriasis in adults and children above the age of six years whose condition has not improved with or who cannot use other systemic whole body psoriasis treatments such as ciclosporin methotrexate or PUVA psoralen ultraviolet A 10 active psoriatic arthritis in adults 10 moderately to severely active Crohn s disease in adults 10 and moderately to severely active ulcerative colitis in adults 10 Adverse effects editAccording to information provided by Centocor maker of one medication based on ustekinumab their version of ustekinumab is associated with several types of serious adverse effects These include an increased risk of infection such as by tuberculosis and an increased risk of certain types of cancer As with some other immunosuppressant drugs like ciclosporin the brain swelling of posterior reversible encephalopathy syndrome is a risk The pharmaceutical company also reports serious allergic reaction as a possible side effect More common side effects are upper respiratory infection headache and tiredness 19 Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated Most treatment emergent adverse events were of mild severity 20 Pregnancy edit It is unknown if the medication is safe during pregnancy or breastfeeding 8 Mechanism of action editUstekinumab is designed to interfere with the triggering of the body s inflammatory response through the suppression of certain cytokines Specifically it blocks interleukin IL 12 and IL 23 which help activate certain T cells It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors 21 History editAs of January 2007 update there were five NIH listed research studies involving CNTO 1275 on a multinational basis including three phase II and two phase III trials Three studies were focused on patients with psoriasis one on psoriatic arthritis and one on multiple sclerosis citation needed On December 4 2007 a Biologic License Application BLA with the US Food and Drug Administration FDA was filed by Centocor and Janssen Cilag International collaborator submitted a Marketing Authorization Application MAA to the European Medicines Agency EMA On November 21 2008 the Committee for Medicinal Products for Human Use CHMP of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies 10 22 Society and culture editLegal status edit Since 2009 ustekinumab is approved in Canada the European Union and the United States to treat moderate to severe plaque psoriasis 23 On September 24 2013 the US Food and Drug Administration FDA approved the use of ustekinumab for the treatment of psoriatic arthritis citation needed On December 12 2008 Health Canada approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy 24 The FDA approved ustekinumab in September 2009 for the treatment of adults with moderate to severe plaque psoriasis 25 26 The FDA approved ustekinumab in September 2016 for the treatment of Crohn s disease 27 Since September 2017 ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn s disease in adults 28 In 2019 the European Commission approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis 14 10 In October 2019 the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis 29 30 Biosimilars edit In October 2023 ustekinumab auub Wezlana was approved for medical use in the United States 2 In November 2023 the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Uzpruvo intended for the treatment of plaque psoriasis including pediatric plaque psoriasis 31 psoriatic arthritis and Crohn s disease in adults 31 The applicant for this medicinal product is STADA Arzneimittel AG 31 Uzpruvo is a biosimilar medicinal product 31 Uzpruvo was approved for medical use in the European Union in January 2024 3 11 In February 2024 the CHMP adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Pyzchiva intended for the treatment of plaque psoriasis including pediatric plaque psoriasis psoriatic arthritis ulcerative colitis and Crohn s disease in adults 32 The applicant for this medicinal product is Samsung Bioepis NL B V 32 Pyzchiva is a biosimilar medicinal product Pyzchiva is a biosimilar medicinal product 32 Ustekinumab aekn Selarsdi was approved for medical use in the United States in April 2024 1 In April 2024 the CHMP adopted a positive opinion recommending the granting of a marketing authorization for the medicinal product Wezenla intended for the treatment of plaque psoriasis including pediatric plaque psoriasis psoriatic arthritis and Crohn s disease in adults 33 The applicant for this medicinal product is Amgen Technology Ireland UC 33 References edit a b c Alvotech and Teva Announce U S FDA Approval of Selarsdi ustekinumab aekn biosimilar to Stelara ustekinumab Press release Alvotech April 16 2024 Archived from the original on April 17 2024 Retrieved April 17 2024 via GlobeNewswire a b c FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases U S Food and Drug Administration Press release October 31 2023 Archived from the original on November 13 2023 Retrieved November 13 2023 nbsp This article incorporates text from this source which is in the public domain a b c Uzpruvo EPAR European Medicines Agency November 9 2023 Archived from the original on January 9 2024 Retrieved January 14 2024 a b c Wezlana APMDS Therapeutic Goods Administration TGA January 30 2024 Archived from the original on February 8 2024 Retrieved March 7 2024 Ustekinumab Stelara Use During Pregnancy Drugs com November 26 2019 Archived from the original on May 22 2020 Retrieved April 6 2020 Prescription medicines and biologicals TGA annual summary 2017 Therapeutic Goods Administration TGA June 21 2022 Archived from the original on March 31 2024 Retrieved March 31 2024 Regulatory Decision Summary for Wezlana Wezlana I V Drug and Health Products Portal December 27 2023 Archived from the original on April 2 2024 Retrieved April 2 2024 a b c d Stelara 45 mg solution for injection vials Summary of Product Characteristics SmPC emc February 27 2020 Archived from the original on April 6 2020 Retrieved April 6 2020 a b c d e f Stelara ustekinumab injection solution Stelara ustekinumab solution DailyMed March 24 2020 Archived from the original on July 2 2019 Retrieved April 6 2020 a b c d e f g h Stelara EPAR European Medicines Agency EMA September 17 2018 Archived from the original on April 6 2020 Retrieved April 6 2020 a b Uzpruvo Product information Union Register of medicinal products January 8 2024 Archived from the original on January 10 2024 Retrieved January 14 2024 a b c Ustekinumab The American Society of Health System Pharmacists Archived from the original on February 2 2017 Retrieved January 8 2017 Cingoz O 2009 Ustekinumab mAbs 1 3 216 221 doi 10 4161 mabs 1 3 8593 PMC 2726595 PMID 20069753 a b EC approves expanded use of Stelara for moderately to severely active ulcerative colitis Healio com Archived from the original on September 9 2019 Retrieved September 26 2019 Ustekinumab Stelara PBS listed for severe Crohn s disease NPS Medicinewise October 26 2017 Archived from the original on April 18 2019 Retrieved October 4 2019 Segal BM Constantinescu CS Raychaudhuri A Kim L Fidelus Gort R Kasper LH September 2008 Repeated subcutaneous injections of IL12 23 p40 neutralising antibody ustekinumab in patients with relapsing remitting multiple sclerosis a phase II double blind placebo controlled randomised dose ranging study The Lancet Neurology 7 9 796 804 doi 10 1016 S1474 4422 08 70173 X PMID 18703004 S2CID 20290673 Reddy M Davis C Wong J Marsters P Pendley C Prabhakar U May 2007 Modulation of CLA IL 12R CD40L and IL 2Ralpha expression and inhibition of IL 12 and IL 23 induced cytokine secretion by CNTO 1275 Cellular Immunology 247 1 1 11 doi 10 1016 j cellimm 2007 06 006 PMID 17761156 Toussirot E April 2012 The IL23 Th17 pathway as a therapeutic target in chronic inflammatory diseases Inflammation amp Allergy Drug Targets 11 2 159 168 doi 10 2174 187152812800392805 PMID 22280236 Important Safety Information Stelara ustekinumab Janssen Biotech May 22 2019 Archived from the original on March 29 2021 Retrieved December 31 2010 Weber J Keam SJ 2009 Ustekinumab BioDrugs 23 1 53 61 doi 10 2165 00063030 200923010 00006 PMID 19344192 S2CID 265771199 Koutruba N Emer J Lebwohl M April 2010 Review of ustekinumab an interleukin 12 and interleukin 23 inhibitor used for the treatment of plaque psoriasis Therapeutics and Clinical Risk Management 6 123 141 doi 10 2147 tcrm s5599 PMC 2857612 PMID 20421912 FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application Drugs com Press release Centocor September 25 2009 Archived from the original on April 6 2020 Retrieved April 6 2020 Medarex to Receive Milestone Payment for Approval of Stelara Ustekinumab for the Treatment of Moderate to Severe Plaque Psoriasis Archived from the original on August 1 2013 Retrieved December 16 2008 drugbank ca Archived from the original on January 31 2020 Retrieved October 4 2019 Stelara approved for moderate to severe psoriasis Sept 2009 September 26 2009 Archived from the original on September 20 2015 Retrieved July 6 2010 Drug Approval Package Stelara Ustekinumab Injection NDA 125261 U S Food and Drug Administration FDA December 24 1999 Archived from the original on April 6 2020 Retrieved April 6 2020 Stelara ustekinumab Injection NDA 761044 U S Food and Drug Administration FDA January 12 2018 Archived from the original on April 6 2020 Retrieved April 6 2020 12 Sept 2017 Archived from the original on March 15 2021 Retrieved October 4 2019 Janssen s Stelara Gets FDA Approval for Ulcerative Colitis FDA News Archived from the original on January 13 2020 Retrieved October 31 2019 Stelara FDA Approved Drugs U S Food and Drug Administration FDA Archived from the original on October 20 2020 Retrieved April 6 2020 a b c d Uzpruvo Pending EC decision European Medicines Agency EMA November 10 2023 Archived from the original on November 10 2023 Retrieved November 13 2023 Text was copied from this source which is copyright European Medicines Agency Reproduction is authorized provided the source is acknowledged a b c Pyzchiva EPAR European Medicines Agency February 22 2024 Archived from the original on February 23 2024 Retrieved February 23 2024 Text was copied from this source which is copyright European Medicines Agency Reproduction is authorized provided the source is acknowledged a b Wezenla EPAR European Medicines Agency April 25 2024 Archived from the original on April 30 2024 Retrieved April 27 2024 Text was copied from this source which is copyright European Medicines Agency Reproduction is authorized provided the source is acknowledged Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Ustekinumab amp oldid 1221465502, wikipedia, wiki, book, books, library,

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