Wikipedia

Ustekinumab

(Redirected from Imuldosa)

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,[27] targeting both IL-12 and IL-23.[28]

Ustekinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL-12 and IL-23
Clinical data
Trade namesStelara
Other namesCNTO 1275
Biosimilarsustekinumab-aekn,[1] ustekinumab-auub,[2] ustekinumab-srlf,[3] ustekinumab-ttwe,[4] Eksunbi,[5][6] Fymskina,[7][8] Imuldosa,[3] Jamteki,[9] Otulfi,[10][11][12] Pyzchiva,[4][13][14] Selarsdi,[1] Steqeyma,[15][16] Uzpruvo,[17] Wezlana,[2][18] Wezenla[19][20]
AHFS/Drugs.comMonograph
MedlinePlusa611013
License data
Pregnancy
category
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Metabolismunknown[24]
Elimination half-life15–32 days (average 3 weeks)[24]
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC6482H10004N1712O2016S46
Molar mass145648.06 g·mol−1
 ☒NcheckY (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.[25][26][29][30] It was found not effective for multiple sclerosis.[31]

It is administered either by intravenous infusion or subcutaneous injection.[27] 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.[32]

Medical uses

edit

Ustekinumab is used to treat psoriasis.[25] This includes psoriatic arthritis when it affects the skin.[27][25] 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.[25][33] It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis.[25]

In the European Union, ustekinumab is authorized for the treatment of moderate to severe plaque psoriasis in people 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);[26] active psoriatic arthritis in adults;[26] moderately to severely active Crohn's disease in adults;[26] and moderately to severely active ulcerative colitis in adults.[26]

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, tiredness,[34] and injection site reactions (such as pain or swelling).[35]

Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.[36]

Pregnancy

edit

It is unknown if the medication is safe during pregnancy or breastfeeding.[24]

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.[37]

History

edit

In December 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). In November 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.[26][38]

Society and culture

edit
edit

Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.[39] In September 2013, the US Food and Drug Administration (FDA) approved the use of ustekinumab for the treatment of psoriatic arthritis.[40]

In December 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.[41][42]

The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.[43][44]

The FDA approved ustekinumab in September 2016, for the treatment of Crohn's disease.[45]

Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.[46]

In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[29][26]

In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.[47][48]

Biosimilars

edit
See also: Biosimilars

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 (EMA) 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,[49] psoriatic arthritis and Crohn's disease in adults.[49] The applicant for this medicinal product is STADA Arzneimittel AG.[49] Uzpruvo is a biosimilar medicinal product.[49] Uzpruvo was authorized for medical use in the European Union in January 2024.[17][50]

In November 2023, Jamteki was approved for medical use in Canada.[9][51]

In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada.[52][53]

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.[13] The applicant for this medicinal product is Samsung Bioepis NL B.V.[13] Pyzchiva is a biosimilar medicinal product.[13] Pyzchiva was authorized for medical use in the European Union in April 2024.[13][14]

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.[19][54] The applicant for this medicinal product is Amgen Technology (Ireland) UC.[19] Wezenla was authorized for medical use in the European Union in June 2024.[19][20]

Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024.[4]

In June 2024, the CHMP recommended granting a marketing authorization for Steqeyma, a biosimilar medicine for the treatment of adults with moderately-to severely-active Crohn's disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis.[15][55] The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.[15] Steqeyma was authorized for medical use in the European Union in August 2024.[15][16]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eksunbi, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults.[5] The applicant for this medicinal product is Samsung Bioepis NL B.V.[5] Eksunbi is a biosimilar medicinal product.[5] Eksunbi is a biosimilar medicinal product.[5] Eksunbi was authorized for medical use in the European Union in September 2024.[5][6]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[10] The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.[10] Otulfi is a biosimilar medicinal product.[10] Otulfi was authorized for medical use in the European Union in September 2024.[10][11]

In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn's disease.[7] The applicant for this medicinal product is Formycon AG.[7] Fymskina is a biosimilar medicinal product.[7] Fymskina was authorized for medical use in the European Union in September 2024.[7][8]

In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada.[56]

In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada.[57][58]

In September 2024, Otulfi was approved for medical use in the United States.[12][59]

Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024.[3][60]

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Absimky, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease or ulcerative colitis.[61] The applicant for this medicinal product is Accord Healthcare S.L.U.[61] Absimky is a biosimilar medicinal product.[61][62]

In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imuldosa, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease.[63] The applicant for this medicinal product is Accord Healthcare S.L.U.[63] Imuldosa is a biosimilar medicinal product.[63]

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. 16 April 2024. Archived from the original on 17 April 2024. Retrieved 17 April 2024 – via GlobeNewswire.
  2. ^ a b c "FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases". U.S. Food and Drug Administration (Press release). 31 October 2023. Archived from the original on 13 November 2023. Retrieved 13 November 2023.   This article incorporates text from this source, which is in the public domain.
  3. ^ a b c "FDA Approves Imuldosa (ustekinumab-srlf), Accord BioPharma's Biosimilar to Stelara (ustekinumab), for the Treatment of Chronic Inflammatory Conditions" (Press release). Accord BioPharma. 14 October 2024. Retrieved 14 October 2024 – via PR Newswire.
  4. ^ a b c "Archived copy" (PDF). Archived (PDF) from the original on 2 July 2024. Retrieved 2 July 2024.{{cite web}}: CS1 maint: archived copy as title (link)
  5. ^ a b c d e f "Eksunbi EPAR". European Medicines Agency. 25 July 2024. Retrieved 29 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ a b "Eksunbi Product information". Union Register of medicinal products. 13 September 2024. Retrieved 17 September 2024.
  7. ^ a b c d e "Fymskina EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ a b "Fymskina PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  9. ^ a b "Summary Basis of Decision for Jamteki". Health Canada. 1 September 2012. Archived from the original on 23 July 2024. Retrieved 23 July 2024.
  10. ^ a b c d e "Otulfi EPAR". European Medicines Agency. 25 July 2024. Archived from the original on 28 July 2024. Retrieved 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ^ a b "Otulfi PI". Union Register of medicinal products. 26 September 2024. Retrieved 30 September 2024.
  12. ^ a b https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf
  13. ^ a b c d e "Pyzchiva EPAR". European Medicines Agency. 22 February 2024. Archived from the original on 23 February 2024. Retrieved 23 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ^ a b "Pyzchiva PI". Union Register of medicinal products. 24 April 2024. Retrieved 30 September 2024.
  15. ^ a b c d "Steqeyma EPAR". European Medicines Agency. 27 June 2024. Archived from the original on 30 June 2024. Retrieved 12 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  16. ^ a b "Steqeyma Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
  17. ^ a b "Uzpruvo EPAR". European Medicines Agency. 9 November 2023. Archived from the original on 9 January 2024. Retrieved 14 January 2024.
  18. ^ a b c "Wezlana APMDS". Therapeutic Goods Administration (TGA). 30 January 2024. Archived from the original on 8 February 2024. Retrieved 7 March 2024.
  19. ^ a b c d "Wezenla EPAR". European Medicines Agency. 25 April 2024. Archived from the original on 6 August 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  20. ^ a b "Wezenla PI". Union Register of medicinal products. 22 June 2024. Archived from the original on 26 June 2024. Retrieved 26 June 2024.
  21. ^ "Ustekinumab (Stelara) Use During Pregnancy". Drugs.com. 26 November 2019. Archived from the original on 22 May 2020. Retrieved 6 April 2020.
  22. ^ "Prescription medicines and biologicals: TGA annual summary 2017". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 31 March 2024. Retrieved 31 March 2024.
  23. ^ "Regulatory Decision Summary for Stelara". Health Canada. 16 June 2020. Retrieved 28 August 2024.
  24. ^ a b c d "Stelara 45 mg solution for injection (vials) - Summary of Product Characteristics (SmPC)". (emc). 27 February 2020. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  25. ^ a b c d e f "Stelara- ustekinumab injection, solution Stelara- ustekinumab solution". DailyMed. 24 March 2020. Archived from the original on 2 July 2019. Retrieved 6 April 2020.
  26. ^ a b c d e f g h "Stelara EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  27. ^ a b c "Ustekinumab". The American Society of Health-System Pharmacists. Archived from the original on 2 February 2017. Retrieved 8 January 2017.
  28. ^ Cingoz O (2009). "Ustekinumab". mAbs. 1 (3): 216–221. doi:10.4161/mabs.1.3.8593. PMC 2726595. PMID 20069753.
  29. ^ a b "EC approves expanded use of Stelara for moderately to severely active ulcerative colitis". Healio.com. Archived from the original on 9 September 2019. Retrieved 26 September 2019.
  30. ^ "Ustekinumab (Stelara) PBS listed for severe Crohn's disease". NPS Medicinewise. 26 October 2017. Archived from the original on 18 April 2019. Retrieved 4 October 2019.
  31. ^ 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.
  32. ^ 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.
  33. ^ 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.
  34. ^ "Important Safety Information". Stelara (ustekinumab). Janssen Biotech. 22 May 2019. Archived from the original on 29 March 2021. Retrieved 31 December 2010.
  35. ^ "Highlights of Prescribing Information" (PDF). U.S. Food and Drug Administration. Retrieved 20 August 2024.
  36. ^ Weber J, Keam SJ (2009). "Ustekinumab". BioDrugs. 23 (1): 53–61. doi:10.2165/00063030-200923010-00006. PMID 19344192. S2CID 265771199.
  37. ^ 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.
  38. ^ "FDA Issues Complete Response Letter to Centocor for Ustekinumab Biologic License Application" (Press release). Centocor. 25 September 2009. Archived from the original on 6 April 2020. Retrieved 6 April 2020 – via Drugs.com.
  39. ^ "Medarex to Receive Milestone Payment for Approval of Stelara (Ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis". Archived from the original on 1 August 2013. Retrieved 16 December 2008.
  40. ^ "New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 31 December 2022. Retrieved 5 August 2024.
  41. ^ "Summary Basis of Decision for Stelara". Health Canada. 27 May 2009. Retrieved 28 August 2024.
  42. ^ "Stelara Product information". Health Canada. 5 January 2009. Archived from the original on 5 August 2024. Retrieved 5 August 2024.
  43. ^ "Stelara approved for moderate to severe psoriasis. Sept 2009". 26 September 2009. Archived from the original on 20 September 2015. Retrieved 6 July 2010.
  44. ^ "Drug Approval Package: Stelara (Ustekinumab) Injection NDA #125261". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  45. ^ "Stelara (ustekinumab) Injection NDA #761044". U.S. Food and Drug Administration (FDA). 12 January 2018. Archived from the original on 6 April 2020. Retrieved 6 April 2020.
  46. ^ "12 Sept 2017". Archived from the original on 15 March 2021. Retrieved 4 October 2019.
  47. ^ "Janssen's Stelara Gets FDA Approval for Ulcerative Colitis". FDA News. Archived from the original on 13 January 2020. Retrieved 31 October 2019.
  48. ^ "Stelara: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 20 October 2020. Retrieved 6 April 2020.
  49. ^ a b c d "Uzpruvo: Pending EC decision". European Medicines Agency (EMA). 10 November 2023. Archived from the original on 10 November 2023. Retrieved 13 November 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  50. ^ "Uzpruvo Product information". Union Register of medicinal products. 8 January 2024. Archived from the original on 10 January 2024. Retrieved 14 January 2024.
  51. ^ "Regulatory Decision Summary for Jamteki". Health Canada. 9 November 2023. Retrieved 28 August 2024.
  52. ^ "Summary Basis of Decision for Wezlana/Wezlana I.V." Health Canada. 1 September 2012. Retrieved 28 August 2024.
  53. ^ "Regulatory Decision Summary for Wezlana/Wezlana I.V." Health Canada. 27 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  54. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Archived from the original on 5 July 2024. Retrieved 13 June 2024.
  55. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  56. ^ "Regulatory Decision Summary for Steqeyma/Steqeyma IV". Health Canada. 30 July 2024. Retrieved 28 August 2024.
  57. ^ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada. 7 August 2024. Retrieved 28 August 2024.
  58. ^ "Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)". Health Canada. 7 August 2024. Retrieved 28 August 2024.
  59. ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf
  60. ^ "US FDA Approves Dong-A ST's Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara" (Press release). Dong-A ST. 11 October 2024. Retrieved 14 October 2024 – via Business Wire.
  61. ^ a b c "Absimky EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  62. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". European Medicines Agency (EMA). 18 October 2024. Retrieved 21 October 2024.
  63. ^ a b c "Imuldosa EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Ustekinumab&oldid=1252404909"