Mirikizumab

Mirikizumab, sold under the brand name Omvoh, is a monoclonal antibody used for the treatment of ulcerative colitis.[1] It is designed to attach to interleukin-23 (IL-23) and block its activity.[1]

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

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).[1]

Mirikizumab was approved for medical use in the European Union in May 2023.[1]

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.[1][2]

History

This drug was developed by Eli Lilly and Co.[3]

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;[4] however, approval in the United States has not been granted due to manufacturing issues.[5]

On 30 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.[6] The applicant for this medicinal product is Eli Lilly Nederland B.V.[6] Mirikizumab was approved for medical use in the European Union in May 2023.[1]

Names

Mirikizumab is the [[international nonproprietary name.[7]

References
  1. "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.
  2. "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.
  3. Statement On A Nonproprietary Name Adopted By The USAN Council - Mirikizumab Archived 27 February 2018 at the Wayback Machine, American Medical Association.
  4. "U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab" (Press release). Eli Lilly and Company. 13 April 2023.
  5. "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.
  6. "Omvoh: Pending EC decision". European Medicines Agency (EMA). 31 March 2023. Archived from the original on 21 May 2023. Retrieved 6 June 2023.
  7. 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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