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Therapeutic Guselkumab antibody from the original Tremfya® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
IL-23 |
Monoclonal Antibody |
Tremfya® |
100 mg/mL |
yes |
4 mg |
-80°C |
2023.12 |
705,00 € |
| Drug name | Tremfya® |
| INN | Guselkumab |
| API type | Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants. |
| ATC code | L04AA24 |
| Target of antibody | TNF alpha |
| General function | Guselkumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Guselkumab alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity. 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 cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to normalize production of these cytokines. Levels of IL-23 are elevated in the skin of patients with plaque psoriasis. In in vitro models, Guselkumab was shown to inhibit the bioactivity of IL-23 by blocking its interaction with cell surface IL-23 receptor, disrupting IL-23-mediated signalling, activation and cytokine cascades. Guselkumab exerts clinical effects in plaque psoriasis and psoriatic arthritis through blockade of the IL-23 cytokine pathway. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | In a phase I study, treatment with guselkumab resulted in reduced expression of IL-23/Th17 pathway genes and psoriasis-associated gene expression profiles, as shown by analyses of mRNA obtained from lesional skin biopsies of patients with plaque psoriasis at Week 12 compared to baseline. In the same phase I study, treatment with guselkumab resulted in improvement of histological measures of psoriasis at Week 12, including reductions in epidermal thickness and T-cell density. In addition, reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab treated patients in phase II and phase III plaque psoriasis studies. These results are consistent with the clinical benefit observed with guselkumab treatment in plaque psoriasis. In psoriatic arthritis patients in phase III studies, serum levels of acute phase proteins C-reactive protein, serum amyloid A, and IL-6, and Th17 effector cytokines IL-17A, IL-17F and IL-22 were elevated at baseline. Guselkumab decreased the levels of these proteins within 4 weeks of initiation of treatment. Guselkumab further reduced the levels of these proteins by Week 24 compared to baseline and also to placebo. |
| Original license holder | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Marketing authorisation numbers | EU/1/07/389/013 |
| Marketing authorisation holder | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Name of the manufacturer of the biological active substance | Biogen Inc. (BIIB) 5000 Davis Drive Research Triangle Park NC27709 USA Janssen Sciences Ireland UC Barnahely Ringaskiddy Co. Cork Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Janssen Biologics B.V. Einsteinweg 101 2333CB Leiden The Netherlands |
| Max shelf life | 2 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Histidine Histidine monohydrochloride monohydrate Polysorbate 80 Sucrose Water for injections |
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