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Le NICE donne le feu vert à la commercialisation de TARGAXAN®▼ 550 en Angleterre et au Pays de Galles


News provided by

Norgine B.V.

Feb 19, 2015, 03:23 ET

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LONDRES, February 19, 2015 /PRNewswire/ --

Première nouveauté depuis 30 ans dans le traitement d'une affection menaçant le pronostic vital liée à la maladie du foie 

TARGAXAN®▼ 550 (rifaximine-α 550 mg), un traitement innovant de l'encéphalopathie hépatique (EH), sera mis à la disposition des patients en Angleterre et au Pays de Galles à la suite de son homologation par le National Institute for Health and Care Excellence (NICE).[1] Liée à la maladie du foie à un stade avancé, l'encéphalopathie hépatique est un trouble neuropsychiatrique grave et susceptible de menacer le pronostic vital qui touche quelque 10 000 patients au Royaume-Uni.[2],[3],[4]  Norgine commercialise ce traitement innovant autorisé sous licence pour la réduction des épisodes d'encéphalopathie hépatique manifeste chez les patients âgés de 18 et plus.[5]

     (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a )

Peter Martin, directeur de l'exploitation chez Norgine, a indiqué : « Norgine est ravie de constater que l'on reconnaît la véritable valeur de TARGAXAN®▼ 550. Cette homologation reflète les avantages qu'apporte le médicament aux patients, aux aidants et au système de santé, comme l'indiquent les données concrètes présentées à l'appui ».

Richard Hall, cofondateur de Liver4Life, a souligné : « Je suis très content de la décision du NICE d'homologuer ce traitement d'une importance cruciale. Les patients souffrant d'EH disposent de très peu de possibilités de traitement car aucun nouveau traitement n'avait été proposé depuis le lancement du lactulose en 1969. Les cliniciens seront désormais en mesure d'offrir un traitement qui fait une énorme différence pour ce qui est de la qualité de vie des patients et de leurs familles ».

Andrew Langford, directeur général du British Liver Trust, a déclaré : « À mon avis, la rifaximine propose aux patients atteints d'encéphalopathie hépatique un traitement inestimable, tout en améliorant considérablement leur qualité de vie et celle de leurs aidants. En tant qu'association caritative travaillant avec de nombreux individus touchés par l'EH, le British Liver Trust se réjouit de la décision du NICE ».

Consultez le communiqué à la page http://www.norgine.com

Références 

1. Décision finale de l'évaluation menée par NICE, « Rifaximin for preventing episodes of overt hepatic encephalopathy », publiée le 19 février 2014 et disponible en ligne sur http://www.nice.org.uk

2. Gitlin N, Lewis DC, Hinkley L. The diagnosis and prevalence of subclinical hepatic encephalopathy in apparently healthy, ambulant, non-shunted patients with cirrhosis. J Hepatol. 1986;3(1):75-82.

3. Gilberstadt SJ, Gilberstadt H, Zieve L, Buegel B, Collier RO, Jr., McClain CJ. Psychomotor performance defects in cirrhotic patients without overt encephalopathy. Arch Intern Med. avril 1980;140(4):519-521

4. Das A, Dhiman RK, Saraswat VA, Verma M, Naik SR. Prevalence and natural history of subclinical hepatic encephalopathy in cirrhosis. J Gastroenterol Hepatol. mai 2001;16(5):531-535.

5. TARGAXAN® 550▼ Résumé des caractéristiques du produit : http://www.medicines.org.uk/emc/medicine/27427/SPC/TARGAXAN+550+mg+film-coated+tablets/

Caroline Ashe +44-(0)7714-061-327
Charlotte Andrews +44-(0)7714-061-485

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