Está usted abandonando el sitio web de Lilly
La liga en la que hizo clic lo llevará a un sitio administrado por un tercero, quien es el único responsable de su contenido. ELI LILLY Y COMPAÑÍA DE MÉXICO S.A. DE C.V. no controla, influye o respalda este sitio, y las opiniones, reclamos o comentarios expresados en este sitio no son responsabilidad de ELI LILLY Y COMPAÑÍA DE MÉXICO S.A. DE C.V. y tampoco la política de privacidad de los sitios web de terceros. Le recomendamos que lea la política de privacidad de cada sitio web que visite. Haga clic en "Continuar" para proceder o "Regresar" para mantenerse en LillyMedical.com/mx
Haga una pregunta para buscar información del producto y recursos médicos de Lilly. Para activar la búsqueda escriba 3 términos.
Por favor no use este campo para reportar eventos adverso o quejas de productos.
Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace:
Información para prescribir
La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.
Galcanezumab: Human vs. Humanized Monoclonal Antibodies
Current evidence suggests designation of a monoclonal antibody as human or humanized does not have an impact on its overall efficacy and safety profile.
The nomenclature assigned to a mAb (ie, human or humanized) is dependent on the variable region of the immunoglobulin. This is the site that provides specificity and affinity for an antibody.1 While there are a number of differences between human and humanized mAbs, current evidence indicates that this designation does not impart a measurable impact on overall efficacy and safety profiles of a given drug. This is reflected in the updated mAb nomenclature recommended by the International Nonproprietary Names Expert Group.2 Clinicians should individually assess each mAb for its clinical impact regarding safety and efficacy.1
Generation of fully human mAbs can
start with either phage display technology or animal immunizations1
be developed in transgenic mice that have been genetically engineered with the human immunoglobulin locus,1 or
have mutations that have been introduced by the mouse somatic mutation machinery.3
Generation of humanized mAbs
starts with animal immunizations, typically utilizing mice
are developed initially in wild type mice with a native genome bearing the mouse immunoglobulin locus
involves grafting the mouse-derived variable region onto a human antibody sequence utilizing molecular engineering technology to generate a humanized mAb
can result in mAbs that, in total, have high human amino acid sequence homology, with differences limited to CDRs within the variable region of the antibody, and
can be specifically engineered to have fully human frameworks with no mutations from germline in these areas.1
Impact on Safety or Efficacy
Changes in the amino acid sequence homology to human amino acid sequences of either fully human or humanized mAbs can contribute to the development of ADAs, thereby potentially limiting clinical efficacy.1
Monoclonal antibodies can provoke neutralizing ADAs which may reduce clinical efficacy. The distinction between fully human and humanized mAbs has no generalizable impact on the development of ADAs based on nomenclature. Rather, a number of intrinsic and extrinsic factors, including but not limited to the amino acid sequence of a mAb, are involved in the development of ADAs for a given therapeutic mAb.1
Galcanezumab: a Humanized Monoclonal Antibody
a humanized IgG4 mAb that binds to CGRP and blocks its binding to the receptor, and
produced in Chinese Hamster Ovary cells by recombinant DNA technology.4
As with all therapeutic proteins there is the potential for immunogenicity with galcanezumab.4
With 12 months of treatment, up to 12.5% of galcanezumab-treated patients developed ADAs, most of which were low titer and tested positive for neutralizing activity in vitro. 4
The presence of ADAs did not affect the pharmacokinetics, efficacy, or safety of galcanezumab.4
1Mallbris L, Davies J, Glasebrook A, et al. Molecular insights into fully human and humanized monoclonal antibodies: what are the differences and should dermatologists care? J ClinAesthetDermatol.2016; 9(7):13-15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5022998/