Jorveza

Authorised

This medicine is authorised for use in the European Union

budesonide

Overview

Jorveza is a medicine used to treat adults and children from the age of two years with eosinophilic oesophagitis. Eosinophilic oesophagitis is inflammation of the oesophagus (the passage that leads from the mouth to the stomach), which causes symptoms such as dysphagia (difficulty swallowing) and blockage of the oesophagus. It is caused by a large build-up of white blood cells called eosinophils in the lining of the oesophagus. 

Eosinophilic oesophagitis is rare, and Jorveza was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 August 2013. 

Jorveza contains the active substance budesonide. 

How is Jorveza used?

Jorveza can only be obtained with a prescription and treatment should be started by a doctor experienced with diagnosing and treating eosinophilic oesophagitis.

Jorveza is available as orodispersible tablets (0.5 mg and 1 mg). The tablet is placed on the tongue and pressed against the roof of the mouth for at least two minutes until it dissolves. During this time the patient should steadily swallow the saliva with the dissolved medicine. Tablets must not be chewed or swallowed whole.

The recommended dose to bring symptoms under control is one 1-mg tablet twice a day for 6 to 12 weeks. To keep the condition under control, treatment with Jorveza can be continued with one 0.5-mg or 1-mg tablet twice a day, depending on how long the patient has had the condition and how severe it is. The doctor will decide how long the treatment should last.

For more information about using Jorveza, see the package leaflet or contact your doctor or pharmacist.

How does Jorveza work?

The active substance in Jorveza, budesonide, is a corticosteroid. Corticosteroids attach to targets (receptors) on immune cells and reduce the release of substances that lead to inflammation.

Budesonide acts in the oesophagus where it reduces the inflammation and relieves the symptoms of eosinophilic oesophagitis. 

What benefits of Jorveza have been shown in studies?

Jorveza was effective in two main studies involving 292 adults with eosinophilic oesophagitis. 

In the first study involving 88 adults with active eosinophilic oesophagitis, treatment with Jorveza (orodispersible tablets) twice a day was compared with placebo (a dummy treatment). The main measure of effectiveness was the level of eosinophils in the oesophagus and improvement in symptoms. After 6 weeks, around 58% of the patients taking Jorveza had reduced eosinophil levels and no symptoms or only minimal symptoms, whereas none of the patients taking placebo had these effects.

In the second study, involving 204 adults whose symptoms of eosinophilic oesophagitis were under control, treatment with a low- and a high-dose of Jorveza (orodispersible tablets) twice a day was compared with placebo. After 48 weeks, symptoms were satisfactorily controlled in around 74% of patients taking low-dose Jorveza twice a day, and in 75% of those taking a higher dose twice a day, compared with 4% of those receiving placebo. 

A third study involving 76 children aged two years and above with eosinophilic oesophagitis compared Jorveza oral suspension with placebo. After 12 weeks, around 46% of children receiving a low dose of Jorveza and 69% of those receiving a high dose had reduced eosinophil levels and no symptoms or only minimal symptoms. This outcome was not seen in children receiving placebo. 

Studies carried out with Jorveza are described in more detail in the medicine’s assessment reports.   

What are the side effects and restrictions with Jorveza?

For the full list of side effects and restrictions with Jorveza, see the package leaflet.

The most common side effects with Jorveza (which may affect more than 1 in 10 people) include fungal infections in the mouth, pharynx (throat) and oesophagus.  

Why is Jorveza authorised in the EU?

The European Medicines Agency decided that Jorveza’s benefits are greater than its risks and it can be authorised for use in the EU.

Patients with eosinophilic oesophagitis often do not have other treatment options. The Agency concluded that Jorveza improves the symptoms of eosinophilic oesophagitis in adults and children and reduces the excess of eosinophils. Jorveza is also effective in preventing recurrent episodes of the disease. Side effects of Jorveza, which mainly affect the mouth and throat, are manageable. 

What measures are being taken to ensure the safe and effective use of Jorveza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jorveza have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Jorveza are continuously monitored. Side effects reported with Jorveza are carefully evaluated and any necessary action taken to protect patients. 

Other information about Jorveza

Jorveza received a marketing authorisation valid throughout the EU on 8 January 2018.

Jorveza : EPAR - Medicine overview

Reference Number: EMADOC-1829012207-45570

Jorveza : EPAR - Risk management plan

Product information

Jorveza : EPAR - Product Information

Jorveza : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Jorveza
• Active substance:
  Budesonide
• International non-proprietary name (INN) or common name:
  budesonide
• Therapeutic area (MeSH):
  Esophageal Diseases
• Anatomical therapeutic chemical (ATC) code:
  A07EA06

Pharmacotherapeutic group

Antidiarrheals, intestinal antiinflammatory / antiinfective agents

Therapeutic indication

Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).

Jorveza 0.2 mg/mL oral suspension is indicated for the treatment of eosinophilic esophagitis (EoE) in paediatric patients 2 to 17 years of age.

Authorisation details

• EMA product number:
  EMEA/H/C/004655
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Dr. Falk Pharma GmbH

  Leinenweber str. 5; 79108 Freiburg; Germany

• Opinion adopted:
  09/11/2017
• Marketing authorisation issued:
  08/01/2018
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Jorveza : EPAR - Procedural steps taken and scientific information after authorisation

Jorveza : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Jorveza-X-0000257468 : EPAR - Assessment report

Adopted Reference Number: EMADOC-1700519818-2989654

CHMP post-authorisation summary of positive opinion for Jorveza (X/0000257468)

Adopted Reference Number: EMADOC-1700519818-2896158

Jorveza-H-C-PSUSA-00010664-202101: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/723487/2021

Jorveza-004655-X-0007-G : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/199925/2020

Initial marketing authorisation documents

Jorveza : Orphan maintenance assessment report (initial authorisation)

Adopted Reference Number: EMA/1001/2018

Jorveza : EPAR - Public assessment report

Adopted Reference Number: EMA/774645/2017