Click here to close now.

Welcome!

.NET Authors: Greg O'Connor, Pat Romanski, Jayaram Krishnaswamy, Adine Deford, Peter Silva

News Feed Item

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
After making a doctor’s appointment via your mobile device, you receive a calendar invite. The day of your appointment, you get a reminder with the doctor’s location and contact information. As you enter the doctor’s exam room, the medical team is equipped with the latest tablet containing your medical history – he or she makes real time updates to your medical file. At the end of your visit, you receive an electronic prescription to your preferred pharmacy and can schedule your next appointment.
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
The WebRTC Summit 2014 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microservices, and more.
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabilities include HD voice, video, multimedia messaging, mobility, conferencing, Web collaboration, deskt...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things compatible devices.
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
SYS-CON Events announced today that Solgenia will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional Social, Mobile and Cloud user experiences, our solutions help large and medium-sized organizations dr...
SYS-CON Events announced today that Liaison Technologies, a leading provider of data management and integration cloud services and solutions, has been named "Silver Sponsor" of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York, NY. Liaison Technologies is a recognized market leader in providing cloud-enabled data integration and data management solutions to break down complex information barriers, enabling enterprises to make smarter decisions, faster.
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the M2M space. This really allows some room for influential individuals to create more high value inter...
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
The list of ‘new paradigm’ technologies that now surrounds us appears to be at an all time high. From cloud computing and Big Data analytics to Bring Your Own Device (BYOD) and the Internet of Things (IoT), today we have to deal with what the industry likes to call ‘paradigm shifts’ at every level of IT. This is disruption; of course, we understand that – change is almost always disruptive.
SYS-CON Events announced today that Akana, formerly SOA Software, has been named “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Akana’s comprehensive suite of API Management, API Security, Integrated SOA Governance, and Cloud Integration solutions helps businesses accelerate digital transformation by securely extending their reach across multiple channels – mobile, cloud and Internet of Things. Akana enables enterprises to share data as APIs, connect and integrate applications, drive part...