Therapeutic Mirikizumab antibody from the original Omvoh® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
Date to be defined |
Omvoh® DE |
80,00 €
/mg
|
Select quantity:
|
mg |
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the reference product.
| Drug name | Omvoh® |
| INN | Mirikizumab |
| API type | Mirikizumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Immunosuppressants, interleukin inhibitors |
| ATC code | L04AC24 |
| Target of antibody | IL-23 |
| General function | |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Mirikizumab is a humanised IgG4 monoclonal, anti-interleukin-23 (anti-IL-23) antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector 9 cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to normalise production of these cytokines. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Inflammatory biomarkers were measured in the phase 3 ulcerative colitis and Crohn’s disease studies. Mirikizumab administered intravenously every 4 weeks during induction dosing significantly reduced levels of fecal calprotectin and C-reactive protein from baseline to week 12. Also, mirikizumab administered subcutaneously every 4 weeks during maintenance dosing sustained significantly reduced levels of fecal calprotectin and C-reactive protein up to 52 weeks. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/23/1736/001 EU/1/23/1736/011 |
| Marketing authorisation holder | Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht The Netherlands |
| Name of the manufacturer of the biological active substance | Eli Lilly Kinsale Limited, Dunderrow, Kinsale, Co. Cork, Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Pre-filled pen, Pre-filled syringe, Vial (1 pack) Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France Vial (3 pack) Lilly S.A., Avda. de la Industria Nº 30, 28108 Alcobendas, Madrid, Spain |
| Max shelf life | 2 years. After dilution Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with sodium chloride 9 mg/mL (0.9 %) solution for 96 hours at 2 °C to 8 °C of which not more than 10 hours are permitted at non-refrigerated temperatures not to exceed 25 ºC, starting from the time of vial puncture. Chemical and physical in-use stability has been demonstrated for diluted infusion solution prepared with 5 % glucose for 48 hours at 2 °C to 8 °C of which not more than 5 hours are permitted at nonrefrigerated temperatures not to exceed 25 °C, starting from the time of vial puncture. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions. Keep the diluted solution away from direct heat or light. Do not freeze the diluted solution. |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium citrate dihydrate (E 331) Citric acid, anhydrous (E 330) Sodium chloride Polysorbate 80 (E 433) Water for injections |
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