Mirikizumab Explained

Type:mab
Mab Type:mab
Source:zu/o
Target:Interleukin 23
Tradename:Omvoh
Dailymedid:Mirikizumab
Pregnancy Au:B1
Routes Of Administration:Intravenous infusion
Atc Prefix:L04
Atc Suffix:AC24
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2] [3]
Legal Us:Rx-only
Legal Us Comment:[4]
Legal Eu:Rx-only
Legal Eu Comment:[5] [6]
Legal Status:JP: Rx-only
Cas Number:1884201-71-1
Drugbank:DB14910
Chemspiderid:none
Unii:Z7HVY03PHP
Kegg:D11123
Synonyms:LY3074828, Mirikizumab-mrkz
C:6380
H:9842
N:1686
O:2004
S:48

Mirikizumab, sold under the brand name Omvoh, is a monoclonal antibody used for the treatment of ulcerative colitis. It is designed to attach to interleukin-23 (IL-23) and block its activity.

The most common side effects include upper respiratory tract infections (nose and throat infections), headache, rash and reactions at the site of injection (when given by injection under the skin).

Mirikizumab was approved for medical use in the European Union in May 2023, and in the United States in October 2023.[7] [8] [9]

Medical uses

In the European Union, mirikizumab is indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

In the United States, mirikizumab is indicated for the treatment of adults with moderately to severely active ulcerative colitis.

History

Mirikizumab was developed by Eli Lilly and Company.[10]

The approval was based on the LUCENT 1 clinical study which evaluated the safety and efficacy of mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.[11]

All participants enrolled in the program had a diagnosis of UC for at least three months prior to baseline and a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).[12] [13]

After twelve weeks of induction treatment, 24% of participants on mirikizumab achieved clinical remission, which compared with 15% for those on a placebo. During the maintenance phase, 66% of mirikizumab takers who had achieved remission at twelve weeks stayed in remission through one year of treatment. Among those who achieved clinical response at twelve weeks, 51% of all mirikizumab-treated participants remained in clinical remission at one year, compared to 27% of those on placebo. Additionally, 99% who achieved clinical remission at one year were steroid-free, and 39% had achieved resolution or near resolution of bowel urgency, which is reported by UC participants as one of the most disruptive symptoms of the condition.[14]

Society and culture

Legal status

In 2023, mirikizumab was approved as a first-in-class treatment for adults with moderately to severely active ulcerative colitis in Japan;[15] however, approval in the United States has not been granted due to manufacturing issues.[16]

In March 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 Omvoh, intended for the treatment of ulcerative colitis. The applicant for this medicinal product is Eli Lilly Nederland B.V.[17] Mirikizumab was approved for medical use in the European Union in May 2023. Mirikizumab was approved for medical use in the United States in October 2023.

Names

Mirikizumab is the international nonproprietary name.[18]

Notes and References

  1. Web site: Omvoh APMDS . Therapeutic Goods Administration (TGA) . 11 October 2023 . 7 March 2024 . 2 January 2024 . https://web.archive.org/web/20240102015253/https://www.tga.gov.au/resources/auspmd/omvoh . live .
  2. Web site: Details for: Omvoh . Drug and Health Products Portal . 5 December 2023 . 3 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303055045/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102858 . live .
  3. Web site: Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26] ]. . 26 October 2023 . 3 January 2024 . 3 January 2024 . https://web.archive.org/web/20240103061027/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2023-10-26.html . live .
  4. Web site: Omvoh- mirikizumab-mrkz injection, solution . DailyMed . 31 October 2023 . 8 November 2023 . 8 November 2023 . https://web.archive.org/web/20231108022506/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=472cbe04-263e-433d-9a0f-58c1b50b715a . live .
  5. Web site: Omvoh EPAR . European Medicines Agency . 8 June 2023 . 8 June 2023 . 8 June 2023 . https://web.archive.org/web/20230608114735/https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. Web site: Omvoh . Union Register of medicinal products . 30 May 2023 . 6 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. Web site: 26 October 2023 . Novel Drug Approvals for 2023 . U.S. Food and Drug Administration (FDA) . 30 October 2023 . 21 January 2023 . https://web.archive.org/web/20230121035617/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 . live .
  8. Web site: 27 October 2023 . Eli Lilly's Omvoh granted FDA approval for ulcerative colitis . 30 October 2023 . PMLive . 30 October 2023 . https://web.archive.org/web/20231030094030/https://www.pmlive.com/pharma_news/eli_lillys_omvoh_granted_fda_approval_for_ulcerative_colitis_1502982 . live .
  9. . FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis . 30 October 2023 . . 30 October 2023 . https://web.archive.org/web/20231030064856/https://www.prnewswire.com/news-releases/fda-approves-lillys-omvoh-mirikizumab-mrkz-a-first-in-class-treatment-for-adults-with-moderately-to-severely-active-ulcerative-colitis-301969505.html . live .
  10. Web site: Statement On A Nonproprietary Name Adopted By The USAN Council - Mirikizumab ]. https://web.archive.org/web/20180227153548/https://searchusan.ama-assn.org/undefined/documentDownload?uri=/unstructured/binary/usan/mirikizumab.pdf . 27 February 2018 . . live .
  11. Web site: CTG Labs - NCBI . 30 October 2023 . clinicaltrials.gov . 27 October 2023 . https://web.archive.org/web/20231027162250/https://clinicaltrials.gov/study/NCT03518086 . live .
  12. Lobatón T, Bessissow T, De Hertogh G, Lemmens B, Maedler C, Van Assche G, Vermeire S, Bisschops R, Rutgeerts P, Bitton A, Afif W, Marcus V, Ferrante M . The Modified Mayo Endoscopic Score (MMES): A New Index for the Assessment of Extension and Severity of Endoscopic Activity in Ulcerative Colitis Patients . Journal of Crohn's & Colitis . 9 . 10 . 846–852 . October 2015 . 26116558 . 10.1093/ecco-jcc/jjv111 . free .
  13. Web site: FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis . 30 October 2023 . BioSpace . 30 October 2023 . https://web.archive.org/web/20231030101315/https://www.biospace.com/article/fda-approves-lilly-s-omvoh-mirikizumab-mrkz-a-first-in-class-treatment-for-adults-with-moderately-to-severely-active-ulcerative-colitis/ . live .
  14. Eli Lilly and Company . Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study . 30 October 2023 . PR Newswire . 30 October 2023 . https://web.archive.org/web/20231030101315/https://www.prnewswire.com/news-releases/lillys-mirikizumab-helps-patients-achieve-clinical-remission-and-improves-symptoms-in-adults-with-ulcerative-colitis-in-12-week-phase-3-induction-study-301247717.html . live .
  15. U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab . Eli Lilly and Company . 13 April 2023 . 26 April 2023 . 26 April 2023 . https://web.archive.org/web/20230426001409/https://www.prnewswire.com/news-releases/us-food-and-drug-administration-issues-complete-response-letter-for-mirikizumab-301796847.html . live .
  16. Web site: FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls . 14 April 2023 . Fierce Pharma . 26 April 2023 . 26 April 2023 . https://web.archive.org/web/20230426001412/https://www.fiercepharma.com/manufacturing/manufacturing-shortfall-trips-eli-lillys-ibd-biologic-fda-rejection . live .
  17. Web site: Omvoh: Pending EC decision . European Medicines Agency (EMA) . 31 March 2023 . 6 June 2023 . 21 May 2023 . https://web.archive.org/web/20230521132640/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/omvoh . live .
  18. ((World Health Organization)) . 2018 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79 . WHO Drug Information . 32 . 1 . 10665/330941 . free . World Health Organization .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Mirikizumab".

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