Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Immunsuppressiv potential

kalcitoningenrelaterad peptid (CGRP) antagonister, såsom galcanezumab, har konstruerats för att binda till antingen CGRP eller dess receptor med hög specificitet och minimerad interaktion med immunsystemet.

CGRP mAbs Have no Direct Specific Immunomodulatory Effect

Antibodies, also referred to as immunoglobulins, are composed of 2 identical heavy and 2 identical light chains.1 These chains contain variable and constant sections, involved in antigen binding and biological activity, respectively. Five isotypes exist in humans including IgA, IgD, IgE, IgG, and IgM. Therapeutic mAbs are composed of IgG isotypes which are divided into 4 subclasses in order of decreasing serum concentrations including IgG1 to IgG4.2 Immunoglobulin G comprises the majority of all antibodies and each IgG subclass has a different ability to activate host immune function.1,2

Therapeutic mAbs are introduced into the host for a specific purpose.1 

The CGRP mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.1-3 As CGRP is not an immune system target, CGRP mAbs have no direct immunomodulatory effect.

The use of galcanezumab is not associated with increased risk of infections or immunosuppression, nor are such events identified as important risks in the galcanezumab risk management plan.4

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, and

  • prevents its biological activity without blocking the CGRP receptor.5


1. Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what headache specialists need to know. Headache. 2015;55(8):1171-1182. http://dx.doi.org/10.1111/head.12642

2. Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for the use of monoclonal antibodies in migraine. Headache. 2018;58(10):1689-1696. http://dx.doi.org/10.1111/head.13439

3. Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics. 2018;15(2):324-335. http://dx.doi.org/10.1007/s13311-018-0622-7

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.


CGRP = calcitonin gene-related peptide

Ig = immunoglobulin

IgA = immunoglobulin A

IgD = immunoglobulin D

IgE = immunoglobulin E

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

IgM = immunoglobulin M

mAb = monoclonal antibody

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M03 19

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