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Mirikizumab

Mirikizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetInterleukin 23
Clinical data
Trade namesOmvoh
Other namesLY3074828, Mirikizumab-mrkz
License data
Pregnancy
category
Routes of
administration		Intravenous infusion
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6380H9842N1686O2004S48
Molar mass143767.59 g·mol−1

Mirikizumab, sold under the brand name Omvoh, is a monoclonal antibody used for the treatment of ulcerative colitis.[5] It is designed to attach to interleukin-23 (IL-23) and block its activity.[5]

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).[5]

Mirikizumab was approved for medical use in the European Union in May 2023,[5] 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.[5][6]

In the United States, mirikizumab is indicated for the treatment of adults with moderately to severely active ulcerative colitis.[7][8]

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][11][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.[13][14]

Society and culture

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.[17] 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.[5] Mirikizumab was approved for medical use in the United States in October 2023.[9]

Names

Mirikizumab is the international nonproprietary name.[18]

References

  1. ^ a b "Omvoh APMDS". Therapeutic Goods Administration (TGA). 11 October 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. ^ "Details for: Omvoh". Drug and Health Products Portal. 5 December 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  3. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Archived from the original on 3 January 2024. Retrieved 3 January 2024.
  4. ^ "Omvoh- mirikizumab-mrkz injection, solution". DailyMed. 31 October 2023. Archived from the original on 8 November 2023. Retrieved 8 November 2023.
  5. ^ a b c d e f g "Omvoh EPAR". European Medicines Agency. 8 June 2023. Archived from the original on 8 June 2023. Retrieved 8 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ a b "Omvoh". Union Register of medicinal products. 30 May 2023. Retrieved 6 June 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ a b "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 26 October 2023. Archived from the original on 21 January 2023. Retrieved 30 October 2023.
  8. ^ a b "Eli Lilly's Omvoh granted FDA approval for ulcerative colitis". PMLive. 27 October 2023. Archived from the original on 30 October 2023. Retrieved 30 October 2023.
  9. ^ a b "FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis" (Press release). Eli Lilly and Company. Archived from the original on 30 October 2023. Retrieved 30 October 2023 – via PR Newswire.
  10. ^ "Statement On A Nonproprietary Name Adopted By The USAN Council - Mirikizumab]" (PDF). American Medical Association. Archived (PDF) from the original on 27 February 2018.
  11. ^ a b "CTG Labs - NCBI". clinicaltrials.gov. Archived from the original on 27 October 2023. Retrieved 30 October 2023.
  12. ^ Lobatón T, Bessissow T, De Hertogh G, Lemmens B, Maedler C, Van Assche G, et al. (October 2015). "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. doi:10.1093/ecco-jcc/jjv111. PMID 26116558.
  13. ^ a b "FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis". BioSpace. Archived from the original on 30 October 2023. Retrieved 30 October 2023.
  14. ^ "Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study" (Press release). Eli Lilly and Company. Archived from the original on 30 October 2023. Retrieved 30 October 2023 – via PR Newswire.
  15. ^ "U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab" (Press release). Eli Lilly and Company. 13 April 2023. Archived from the original on 26 April 2023. Retrieved 26 April 2023.
  16. ^ "FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls". Fierce Pharma. 14 April 2023. Archived from the original on 26 April 2023. Retrieved 26 April 2023.
  17. ^ a b "Omvoh: Pending EC decision". European Medicines Agency (EMA). 31 March 2023. Archived from the original on 21 May 2023. Retrieved 6 June 2023.
  18. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information. 32 (1). hdl:10665/330941.


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