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Therapeutic Abatacept antibody from the original Orencia® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
CD80 , CD86 |
Fusion protein |
Orencia® |
25 mg/mL |
yes |
5 mg |
-80°C |
02/2023 |
194,40 € |
| Drug name | Orencia® |
| INN | Abatacept |
| API type | Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in Chinese hamster ovary cells. |
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants. |
| ATC code | L04AA24 |
| Target of antibody | TNF alpha |
| General function | Abatacept, in combination with methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. It is also indicated for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28. Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal. A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2). Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86. Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin-2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute-phase reactant of inflammation. In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased. Reductions in serum TNFα were also observed. |
| Original license holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Marketing authorisation numbers | EU/1/07/389/013 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Co. 38 Jackson Road Devens, MA 01434 USA |
| Name and address of the manufacturer(s) responsible for batch release | CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale 12 Casilina, 41 03012 Anagni (FR) Italy Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15 Ireland |
| Max shelf life | 3 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Maltose Sodium dihydrogen phosphate monohydrate Sodium chloride |
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