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Therapeutic Brodalumab antibody from the original Kyntheum® 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-17RA |
Monoclonal Antibody |
Kyntheum® |
140 mg/mL |
– |
7 mg |
-80°C |
05/2022 |
257,40 € |
| Drug name | Kyntheum® |
| INN | Brodalumab |
| API type | Monoclonal antibody |
| Pharmacotherapeutic group | Immunosuppressants, Interleukin inhibitors. |
| ATC code | L04AC12 |
| Target of antibody | IL-17RA |
| General function | Brodalumab is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Elevated levels of IL-17A, IL-17C and IL-17F gene expression are found in psoriatic plaques. Elevated levels of expression of IL-12B and IL-23A, the genes for the two subunits of IL-23, an upstream activator of IL-17A and IL-17F expression, are also found in psoriatic plaques. |
| Original license holder | LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark |
| Marketing authorisation numbers | EU/1/16/1155/001, EU/1/16/1155/002 |
| Marketing authorisation holder | LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark |
| Name of the manufacturer of the biological active substance | Immunex Rhode Island Corporation 40 Technology Way, West Greenwich, Rhode Island, 02817 United States |
| Name and address of the manufacturer(s) responsible for batch release | Laboratoires LEO 39 route de Chartres 28500 Vernouillet France LEO Pharma A/S Industriparken 55 DK-2750 Ballerup Denmark |
| Max shelf life | 4 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Proline Glutamate Polysorbate 20 Water for injections |
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