Brodalumab

Therapeutic Brodalumab antibody from the original Kyntheum® commercial drug.

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Product
Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
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Expiry Date
Price
IL-17RA
Monoclonal Antibody
Kyntheum®
140 mg/mL
7 mg
-80°C
05/2022
254,00 
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Kyntheum® / Brodalumab Reference Product

Drug nameKyntheum®
INNBrodalumab
API typeMonoclonal antibody
Pharmacotherapeutic group
Immunosuppressants, Interleukin inhibitors.
ATC code
L04AC12
Target of antibody
IL-17RA
General functionBrodalumab 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 releaseLaboratoires 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
Evidentic Support
+49 (0) 30 959 99 8831

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