Type of information: Granting of a Market Authorisation in the EU
Product name: Jorveza®
Therapeutic area: Rare diseases - Inflammatory diseases - Digestive diseases
- corticosteroid. Budesonide is a locally acting corticosteroid which works primarily via binding to the glucocorticoid receptor. In the treatment of eosinophilic esophagitis, budesonide inhibits antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, resulting in a significant reduction of the esophageal eosinophilic inflammatory infiltrate.
Company: Dr Falk Pharma GmbH (Germany)
Disease: eosinophilic oesophagitis in adults
- • On 9 November 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Jorveza®, intended for the treatment of eosinophilic esophagitis. The drug which was designated as an orphan medicinal product on 05 August 2013, was reviewed under EMA’s accelerated assessment programme.
- Jorveza® will be available as 1-mg orodispersible tablets. The benefits with Jorveza® are its ability to reduce eosinophil infiltrations into the oesophageal mucosa and reduce relevant symptoms of the disease such as dysphagia and pain during swallowing. The most common side effects seen in studies were fungal infections both of the oesophagus and the oral cavity (including the pharynx), which occur in about 30% of the population treated. However these infections did not lead to treatment discontinuation, were mostly asymptomatic, and, in most cases, were treated successfully with standard antifungal treatments. Further common side effects observed were headache, nausea, dyspepsia, interaction with CYP3A4 inhibitors, gastroesophageal reflux disease, decreased cortisol levels and lip oedema.
- • On 9-11 July 2013, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for budesonide for treatment of eosinophilic oesophagitis.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
UE authorization: 2018-01-08
Favourable opinion UE: 2017-11-09
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2013-08-05
Pediatric exclusivit _USA:
Pediatric exclusivity UE: