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El grupo Galés AWMSG y el Consorcio Escocés de Medicamentos aceptan el uso de la nueva presentación bebible y apta para niños de Inovelon® (rufinamida)

HATFIELD, Inglaterra, November 6, 2012 /PRNewswire/ --

Esta nueva opción ofrece posibilidades de elección para los niños y jóvenes con síndrome de Lennox-Gastautuna forma grave de epilepsia

El grupo AWMSG (All Wales Medicines Strategy Group) y el Consorcio Escocés de Medicamentos (SMC) han aceptado el uso de Inovelon® (rufinamida) en suspensión oral en Gales y Escocia respectivamente, para el tratamiento coadyuvante de las crisis relacionadas con el síndrome de Lennox-Gastaut (SLG), una forma de epilepsia muy debilitante, en niños a partir de cuatro años. El AWMSG y el SMC ha limitado su uso a pacientes en los que haya fracasado el tratamiento con otros fármacos antiepilépticos o muestren intolerancia a los mismos.[1],[2]

La decisión del AWMSG y el SMC de aceptar el uso de la suspensión oral de rufinamida es posterior a su aprobación de la formulación de comprimidos en 2008, sustentada en datos que indican que es capaz de reducir la frecuencia de las crisis totales y las tónicas/atónicas de forma significativa, además de reducir la gravedad de las crisis de forma significativa, en comparación con placebo en pacientes con SLG.[3] La suspensión oral ha demostrado su bioequivalencia y supone un impacto presupuestario mínimo en Gales y Escocia, por lo que ha sido aprobada siguiendo un procedimiento abreviado. Muchos de los pacientes tratados con rufinamida, un medicamento huérfano, son niños. Esta nueva presentación apta para niños, líquida, bebible y con sabor naranja se ha desarrollado para facilitar la administración del tratamiento

«Como a algunos niños les resulta difícil tragar los comprimidos convencionales, existe una gran necesidad de medicinas bebibles, en especial al tratar a pacientes jóvenes de SLG», explica Helen Cross, Directora de la Unidad de Neurociencia del University College London, Instituto de Salud Infantil. «El acceso a la formulación de suspensión de rufinamida puede ayudar a los jóvenes a seguir mejor el tratamiento, lo que permitirá obtener mejores resultados en el tratamiento de esta enfermedad grave y muy debilitante».

El SLG es una forma de epilepsia poco frecuente pero grave que representa un cinco por ciento de todos los casos y supone aproximadamente el 10 por ciento de los casos de epilepsia infantil.[4] La incidencia anual de la enfermedad afecta a aproximadamente 2,8 de cada 10.000 nacimientos en Europa.[4] El seguimiento del tratamiento es vital para el correcto manejo del SLG en los niños, ya que la enfermedad se caracteriza por numerosas crisis diarias, retraso mental y regresión.[5]

«La aprobación del AWMSG y el SMC de la nueva presentación líquida de rufinamida es importante, ya que permitirá abordar las necesidades de seguimiento de los niños y jóvenes con esta forma grave de epilepsia», afirma Mike Bee, director de la unidad de negocio de epilepsia para el norte de la UE. «Estas aprobaciones están en línea con nuestro compromiso continuo con el área terapéutica de la epilepsia y ejemplifica nuestro objetivo de aumentar los beneficios que ofrecen nuestras medicinas a los pacientes y sus familias a través de la misión de  Eisai con el cuidado de la salud humana (hhc por sus siglas en inglés)».

La dosis de la suspensión oral es equivalente en miligramos a los comprimidos de rufinamida comercializados actualmente. La aprobación del AWSMG y el SMC para el uso de la suspensión oral se produce después de su comercialización en Inglaterra, los Países Bajos y Alemania. La nueva formulación se presentará en otros países europeos este mismo año.

La rufinamida en suspensión oral recibió la opinión positiva del CHMP en septiembre de 2011 y obtuvo la aprobación formal de la EMA en noviembre de 2011. El medicamento fue aprobado por la FDA y se comercializó en los Estados Unidos en marzo de 2011 (la rufinamida se comercializa como BANZEL® en los Estados Unidos).  

Acerca de Inovelon® (rufinamida)

La rufinamida es un derivado de triazol que carece de relación estructural con los fármacos antiepilépticos (FAE) que se comercializan actualmente. Se cree que regula la actividad de los canales de sodio del cerebro que transmiten cargas eléctricas excesivas. El agente se aprobó como terapia coadyuvante para el SLG en Europa (con el nombre comercial de Inovelon) en 2007.[2] Inovelon está disponible en forma de comprimidos recubiertos que contienen 100 mg, 200 mg y 400 mg de rufinamida.

La formulación de rufinamida en comprimidos recubiertos se comercializó por primera vez en Europa en mayo de 2007 y actualmente está disponible en 19 países europeos.

Acerca del síndrome de Lennox-Gastaut

El SLG es una forma debilitante de epilepsia de inicio infantil que aparece con mayor frecuencia entre las edades de dos a siete años. Se caracteriza por crisis frecuentes y de múltiples tipos y suele ir acompañada de retraso mental y problemas psicológicos y de comportamiento.[6]

Acerca de la epilepsia

La epilepsia es uno de los trastornos neurológicos más comunes del mundo, que afecta aproximadamente a 8 de cada 1.000 personas en Europa y se estima que hay 50 millones de personas con este trastorno en todo el mundo, 10,5 millones de las cuales son niños menores de 15 años.[7],[8],[9] En Escocia, este trastorno afecta a casi 40.000 personas.[10]

La epilepsia se caracteriza por la generación anormal de impulsos desde las células nerviosas del cerebro que causan las crisis. Según el tipo, las crisis pueden limitarse a una parte del cerebro (parciales) o pueden ser generalizadas cuando le afectan en su totalidad.

Los pacientes también pueden experimentar sensaciones anormales, alteraciones del comportamiento o alteraciones de la consciencia. La epilepsia es un trastorno que tiene muchas causas posibles. Con frecuencia estas causas son desconocidas. Sin embargo, cualquier factor que altere la actividad normal de las neuronas, desde una enfermedad hasta daños cerebrales o tumores, puede producir una crisis.[11]

Acerca de Eisai Europa en relación con la epilepsia

Eisai está comprometida con el desarrollo y el suministro de nuevos tratamientos beneficiosos para ayudar a mejorar las vidas de las personas con epilepsia. El desarrollo de FAE es una importante área estratégica para Eisai en Europa, Oriente Medio, África y Rusia (EMEA).

En Europa, Eisai comercializa actualmente cuatro medicamentos:

  • Zonegran® (zonisamida) como monoterapia y tratamiento coadyuvante en pacientes adultos con crisis de inicio parcial con generalización secundaria o sin ella. (Zonegran está bajo licencia de Dainippon Sumitomo Pharma)
  • Zebinix® (acetato de eslicarbazepina) como tratamiento adyuvante en pacientes adultos con crisis de inicio parcial, con o sin generalización secundaria. En España, el representante local del laboratorio titular de la autorización de comercialización de Zebinix® en la Unión Europea es Bial Industrial Farmacéutica, S.A.
  • Inovelon® (rufinamida) para el tratamiento adyuvante en pacientes de 4 y más años de crisis asociadas con el síndrome de Lennox-Gastaut.
  • Fycompa® (perampanel) como tratamiento coadyuvante para las crisis de inicio parcial, con crisis secundarias generalizadas o sin ellas, en pacientes con epilepsia mayores de 12.

Acerca de Eisai

Eisai ha ampliado recientemente sus instalaciones comerciales, de investigación y producción en Hatfield, Reino Unido, que ahora respaldan el crecimiento del negocio de la empresa en EMEA.

Eisai concentra sus actividades de I+D en tres áreas fundamentales:

  • Área de Neurociencias, que incluye enfermedad de Alzheimer, dolor neuropático, epilepsia, dolor y pérdida de peso.
  • Área de Oncología: tratamientos contra el cáncer; regresión tumoral, supresión tumoral, anticuerpos, etc.
  • Vascular / respuesta inmunológica, incluyendo trombocitopenia, artritis reumatoide, psoriasis, enfermedad inflamatoria intestinal.

Con filiales en los Estados Unidos, Asia, Europa y Japón, Eisai tiene más de 11.000 empleados en todo el mundo. En Europa, Eisai tiene filiales comerciales en más de 20 países que incluyen el Reino Unido, Francia, Alemania, Italia, España, Suiza, Suecia, Irlanda, Austria, Dinamarca, Finlandia, Noruega, Portugal, Islandia, República Checa, Eslovaquia, Países Bajos y Bélgica.

Si desea más información visite nuestro sitio web http://www.eisai.com

Bibliografía

1.  Scottish Medicines Consortium. Inovelon product update. http://www.scottishmedicines.org.uk/files/advice/rufinamide_Inovelon_ABBREVIATED_June_2012_for_website.pdf. Last accessed 3 September 2012

2.  All Wales Strategic Medicines Group. Inovelon product update. http://www.wales.nhs.uk/sites3/Documents/371/rufinamide%20%28Inovelon%29%20FAR.pdf
Last accessed 2 November 2012

3.  Inovelon tablets Summary of Product Characteristics http://www.medicines.org.uk/emc/medicine/20165/SPC/ (Accessed January 2012)

4.  Kenou van Rijckevorsel Treatment of Lennox-Gastaut syndrome: overview and recent findings. Neuropsychiatr Dis Treat. 2008 December; 4(6): 1001-1019.

5.  MedScape references Lennox-Gastaut Syndrome http://emedicine.medscape.com/article/1176735-overview (Accessed February 2012)

6.  International Journal of Pharma and Bio Sciences. http://www.ijpbs.net/issue-3/82.pdf (Accessed February 2012)

7.  Forsgren L. Epilepsy in Children. 2nd Ed London. Arnold, 2004. 21-25

8.  Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233

9.  Epilepsy Society UK: http://www.epilepsysociety.org.uk/AboutEpilepsy/Whatisepilepsy/Epilepsy-didyouknow (Accessed February 2012)

10. Epilepsy Scotland available at: http://www.epilepsyscotland.org.uk/ (Accessed 01 November 2010). 11.     Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed February 2012)

11. Epilepsy Research UK. What is Epilepsy? Fact sheet. Available from URL: http://www.epilepsyresearch.org.uk/about_us/leaflets/lflt1.htm (Accessed February 2012)

Fecha de preparación: noviembre de 2012
Código de trabajo: Inovelon-UK2271

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