PROCYSBI (cysteamine), metabolism product
RARE DISEASE - New medicinal product
Opinions on drugs -
Posted on
Jan 08 2016
Reason for request
Inscription
- PROCYSBI 25 mg and 75 mg have Marketing Authorisation in the treatment of proven nephropathic cystinosis.
- The presentation takes the form of prolonged-release gastro-resistant hard capsules, which need to be taken only once every 12 hours.
- It is an alternative to CYSTAGON (same active ingredient, but immediate release), which is the only other medicinal product with Marketing Authorisation in nephropathic cystinosis.
- PROCYSBI was found to be non-inferior to CYSTAGON in terms of maintenance of intraleukocytic cystine levels in patients managed with CYSTAGON.
Clinical Benefit
Substantial |
Le service médical rendu par PROCYSBI est important dans le traitement de la cystinose néphropathique confirmée. |
Clinical Added Value
minor |
La Commission considère que PROCYSBI, spécialité à base de bitartrate de cystéamine à libération prolongée, apporte une amélioration du service médical rendu mineure (ASMR IV) par rapport à CYSTAGON, formulation à libération immédiate du même principe actif. |
English version
Contact Us
Évaluation des médicaments