Mirikizumab

Therapeutic Mirikizumab antibody from the original Omvoh® commercial drug.

Reference Standard as Aliquots

Omvoh®
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Product Information

Here you will find the product information for the reference product.

Omvoh® / Mirikizumab Reference Product

Drug nameOmvoh®
INNMirikizumab
API typeMirikizumab 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 releasePre-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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