VOLIBRIS - VOLIBRIS - CT 6314 - English version

Has

Description

Introduction VOLIBRIS 5 mg film-coated tablets B/30 (CIP code: 386 578-1) VOLIBRIS 10 mg film-coated tablets B/30 (CIP code: 386 580-6) Posted on Jan 05 2011 Active substance (DCI) ambrisentan Pneumologie - Mise au point Progrès thérapeutique :– important pour FLOLAN ;– modéré pour TRACLEER ;– mineur pour ADCIRCA, REMODULIN, REVATIO, VENTAVIS et VOLIBRIS Les médicaments de l’hypertension artérielle pulmonaire (HTAP) n'apportent qu'un bénéfice symptomatique, et celui-ci est modeste.FLOLAN (époprosténol) est le seul ayant montré une augmentation de la survie. Son rapport efficacité/effets indésirables est donc important ; il est modéré pour les autres médicaments.Il s’agit de médicaments de première intention, excepté REMODULIN et VENTAVIS, qui sont utilisés en deuxième intention.N.B. – THELIN a été retiré du marché en raison de son risque d'atteinte hépatique sévère.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code C02KX02 Laboratory / Manufacturer GLAXOSMITHKLINE VOLIBRIS 5 mg film-coated tablets B/30 (CIP code: 386 578-1) VOLIBRIS 10 mg film-coated tablets B/30 (CIP code: 386 580-6) Posted on Jan 05 2011

Sujets

• Maladie génétique
• RARE

Informations

• Publié par: haute-autorite-sante-maladies-appareil-respiratoire
• Publié le: 05 janvier 2011
• Nombre de lectures: 11
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

  The legally binding text is the original French version  

TRANSPARENCY COMMITTEE   OPINION   5 January 2011     VOLIBRIS 5 mg film-coated tablets B/30 (CIP code: 386 578-1) VOLIBRIS 10 mg film-coated tablets B/30 (CIP code: 386 580-6)     Applicant: GLAXOSMITHKLINE   ambrisentan  ATC code: C02KX02   List I Medicine for hospital prescription only, restricted to specialists and/or departments specialising in pneumology, cardiology, or internal medicine. Medicine requiring special monitoring during treatment.   Date of Marketing Authorisation (centralised procedure): 21 April 2008 Orphan drug (designation granted on 11 April 2005)   Reason for examination: Reassessment of actual benefit and improvement in actual benefit under article R-163-21 of the Social Security Code.   Indications:   “VOLIBRIS is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH and in PAH related to systemic collagen disease.”   Dosage: see SPC   The Transparency Committee has reassessed all treatments for PAH. Distinctions have been drawn between the various drugs (see complete report attached). The Transparency Committee’s conclusions regarding VOLIBRIS were as follows:  

 

1/2

Actual benefit PAH is a rare pulmonary condition that affects life expectancy. It is characterised by gradual blocking of the small pulmonary arteries, leading to a gradual increase in pulmonary arterial pressure and right cardiac insufficiency. PAH is defined by an increase in mean pulmonary arterial pressure (mPAP) measured by cardiac catheterisation which is equal to or greater than 25 mmHg at rest, with no increase in pulmonary capillary pressure. Asthenia, dyspnoea, chest pain and loss of consciousness are the most frequent clinical signs. Median survival under symptomatic treatment is around 2.5 years for patients with functional class III PAH and 4.8 years for those with functional class II PAH.   All treatments for PAH are in the symptomatic category. The efficacy/adverse effects ratio is moderate. This medicinal product is a first-line therapy.   No public health benefit is expected.   The actual benefit is moderate.   Improvement in actual benefit (IAB) The Transparency Committee considers that the REVATIO range of proprietary drugs provides a minor improvement in actual benefit (IAB IV) in the treatment of idiopathic pulmonary arterial hypertension, or pulmonary arterial hypertension associated with systemic collagen disease, for patients in functional class II or III.   The Transparency Committee will reassess VOLIBRIS products in the light of the findings of the European reassessment of the hepatotoxicity of endothelin antagonists.   The Transparency Committee expresses the wish, at the request of the Directorate General for Health, that proprietary products administered via the oral route be made available for prescription outside hospital.                       Medical, Economic and Public Health Assessment Division

 

2/2