Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized (from mouse) |
Target | Interleukin 23 |
Clinical data | |
Trade names | Omvoh |
Other names | LY3074828 |
Routes of administration | Intravenous infusion |
ATC code |
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Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6380H9842N1686O2004S48 |
Molar mass | 143767.59 g·mol−1 |
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]
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]
In October 2023, the FDA approved mirikizumab for the treatment of moderately to severely active ulcerative colitis. [3] [4] [5]
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]
In the US, mirikizumab-mrkz) is indicated for the treatment of adults with moderately to severely active ulcerative colitis. [3] [4]
This drug was developed by Eli Lilly and Co. [6]
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. [7]
All patients enrolled in the programme had a diagnosis of UC for at least 3 months prior to baseline and a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). [8] [7] [9]
After 12 weeks of induction treatment, 24% of patients 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 12 weeks stayed in remission through one year of treatment. Among those who achieved clinical response at 12 weeks, 51% of all Omvoh-treated patients 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 patients as one of the most disruptive symptoms of the condition. [9] [10]
In 2023, mirikizumab was approved as a first-in-class treatment for adults with moderately to severely active ulcerative colitis in Japan; [11] however, approval in the United States has not been granted due to manufacturing issues. [12]
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. [13] The applicant for this medicinal product is Eli Lilly Nederland B.V. [13] Mirikizumab was approved for medical use in the European Union in May 2023. [1] Mirikizumab was approved for medical use in the US in October 2023. [5]
Mirikizumab is the international nonproprietary name. [14]
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD). It is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptoms of active disease are abdominal pain and diarrhea mixed with blood (hematochezia). Weight loss, fever, and anemia may also occur. Often, symptoms come on slowly and can range from mild to severe. Symptoms typically occur intermittently with periods of no symptoms between flares. Complications may include abnormal dilation of the colon (megacolon), inflammation of the eye, joints, or liver, and colon cancer.
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals.
Biological therapy, the use of medications called biopharmaceuticals or biologics that are tailored to specifically target an immune or genetic mediator of disease, plays a major role in the treatment of inflammatory bowel disease. Even for diseases of unknown cause, molecules that are involved in the disease process have been identified, and can be targeted for biological therapy. Many of these molecules, which are mainly cytokines, are directly involved in the immune system. Biological therapy has found a niche in the management of cancer, autoimmune diseases, and diseases of unknown cause that result in symptoms due to immune related mechanisms.
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