following a full submission:
budesonide (Jorveza®) is accepted for restricted use within NHSScotland.
Indication under review: Treatment of eosinophilic oesophagitis (EoE) in adults (older than 18 years of age).
SMC restriction: For patients unsuccessfully treated with proton pump inhibitors.
One randomised, double-blind phase III study, demonstrated superiority of budesonide over placebo in inducing clinico-histologic remission in adult patients with EoE, refractory to treatment with a proton pump inhibitor.
The case presented to SMC was for induction of remission. The marketing authorisation for budesonide (Jorveza®) has subsequently been extended to include maintenance of remission. SMC does not plan to assess this licence extension.
- Medicine name:
- budesonide (Jorveza)
- SMC ID:
For the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
- Pharmaceutical company
- Dr Falk Pharma UK
- BNF chapter
- Gastro-intestinal system
- Submission type
- Date advice published
- 12 October 2020