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    AVISO
    Inicio > Historias > Autorizado un nuevo ATMP: ZYNTEGLO 2019-06-06

    Autorizado un nuevo ATMP: ZYNTEGLO

    Comentábamos hace unos días sobre Zynteglo y su próxima Marketing Autorización.

    La EMA el pasado día 3 de junio de 2019 emitió la correspondiente EPAR de la que extraemos lo siguiente:

     2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA

    2.1. Descripción general

     Población enriquecida con células CD34+ autólogas genéticamente modificadas que contiene células progenitoras hematopoyéticas (CPH) transducidas con el vector lentiviral (LVV, por sus siglas en inglés) que codifica el gen de β A -T87Q -globina

    ...

    4. DATOS CLÍNICOS

     4.1. Indicaciones terapéuticas

    Zynteglo está indicado para el tratamiento de pacientes de 12 años y mayores con β-talasemia dependiente de transfusión (TDT) que no tienen un genotipo β 0 /β 0, para quienes el trasplante de células progenitoras hematopoyéticas (CPH) es adecuado, pero no se dispone de un donante de CPH-antígeno leucocitario humano (HLA, por sus siglas en inglés) compatible emparentado (ver las secciones 4.4 y 5.1)

     ...


     5. PROPIEDADES FARMACOLÓGICAS

     5.1. Propiedades farmacodinámicas

     Grupo farmacoterapéutico: Otros agentes hematológicos, código ATC: no se ha asignado aún

    Mecanismo de acción

    Zynteglo añade copias funcionales de un gen modificado de la β-globina en las CPH de los pacientes a través de la transducción de células CD34+ autólogas con BB305 LVV, abordando así la causa genética subyacente de la enfermedad. Después de la perfusión de Zynteglo, las CPH CD34 + transducidas se implantan en la médula ósea y se diferencian para producir ERI que contienen βA - T87Q – globina biológicamente activa (una proteína β-globina modificada) que se combinarán con la α-globina para producir Hb funcional con β A - T87Q –globina (Hb A T87Q ). La β A - T87Q – globina se puede cuantificar con respecto a otras especies de globinas en sangre periférica con cromatografía líquida de alto rendimiento. La expresión de la β A - T87Q – globina está diseñada para corregir el desequilibrio β/α – globina en las células eritroides de pacientes con TDT y tiene el potencial de aumentar la Hb total hasta niveles normales y eliminar la dependencia de transfusiones crónicas de ERI.Tras el éxito del injerto y de lograr la independencia de transfusión, se prevé que los efectos del producto sean de por vida.


    Efectos farmacodinámicos 

    Todos los pacientes con TDT con un genotipo no-β 0 /β0 que recibieron Zynteglo con al menos 3 meses de seguimiento produjeron HbAT87Q (N = 10, HGB-204; N = 4, HGB-205; N = 14, HGB-207; N = 1, HGB-212). En los pacientes con al menos 6 meses de seguimiento, en general la HbAT87Q aumentó de forma constante después de la perfusión de Zynteglo y de manera aproximada, se estabilizó, en el mes 6 a 9 después de la perfusión. Los pacientes presentaron una mediana (mín, máx) de HbAT87Q a los 6 meses de 4,90 (1,0, 9,6) g/dl en los estudios en fase I/II (N = 14, HGB-204 y HGB-205) y 9,49 (3,4, 10,6) g/dl en el estudio en fase III en curso (N = 11, HGB-207). Por lo general, la HbAT87Q se mantuvo estable hasta el mes 24 con una mediana (mín, máx) de 6,44 (1,1, 10,1) g/dl (N = 14, HGB-204 y HGB-205) y a lo largo del seguimiento a largo plazo en LTF-303, demostrando una integración estable del gen de la β A-T87Q-globina en las CPH a largo plazo y una expresión estable del gen de la β A-T87Q-globina en las células de linaje eritroide.

    ...


    Respecto de los ensayos clínicos copiamos la Tabla 5 con los resultados para los estudios HGB-205, HGB-204 y  HGB-207





     7. TITULAR DE LA AUTORIZACIÓN DE COMERCIALIZACIÓN

     bluebird bio (Netherlands) B.V.

     Stadsplateau 7

     WTC Utrecht

    3521AZ Utrecht

    Países Bajos


    2019-06-06 06:17 | 19 Comentarios


    Referencias (TrackBacks)

    URL de trackback de esta historia http://prueba.blogalia.com//trackbacks/77928

    Comentarios

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