ENTOCORT (budesonide), locally acting corticosteroid

GASTROENTEROLOGY - New indication
Opinions on drugs - Posted on Oct 24 2018

Reason for request

Extension of indication

High clinical benefit in active microscopic colitis, but no demonstrated clinical benefit in the therapeutic strategy

 

  • ENTOCORT has been granted marketing authorisation in remission induction treatment in patients suffering from active microscopic colitis.

  • Its efficacy is suggested by data of poor methodological quality, particularly in lymphocytic colitis.

  • It has not been compared to MIKICORT, another budesonide-based medicinal product having been granted marketing authorisation in collagenous colitis, or to other symptomatic treatments used off-label in practice (loperamide, 5 ASA, cholestyramine, etc.).

 


Clinical Benefit

Substantial

-


Clinical Added Value

no clinical added value

-