European Commission approves Jorveza® suspension

European Commission approves Jorveza® suspension European Commission approves Dr. Falk Pharma’s Jorveza ® suspension for children and adolescents with eosinophilic esophagitis Freiburg, April 17th, 2026 Dr. Falk Pharma GmbH today announced that the European Commission (EC) has granted marketing authorization for Jorveza ® oral suspension (budesonide) for the treatment of eosinophilic esophagitis (EoE) in pediatric patients 2 to 17 years of age. ¹ The approval is based on data from PEDEOS-1, a phase 2/3 clinical trial evaluating Jorveza ® oral suspension versus placebo in children and adolescents aged 2 to 17 years with EoE. 1 After 12 weeks of treatment, 7 out of 10 patients (69.2%, p < 0.0001) receiving Jorveza ® oral suspension achieved the primary endpoint (histological remission and clinical response), compared with 0 patients (0.0%) receiving placebo. 1 Clinical remission was maintained and further improved in a 24-week open-label extension phase following the induction period. The incidence of treatment-emergent adverse events (TEAEs) in the PEDEOS-1 study was similar in patients receiving Jorveza ® suspension and those receiving placebo, with the majority being mild in severity. 2 About eosinophilic esophagitis (EoE) Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus that can affect individuals from infancy through adulthood. The term “eosinophilic esophagitis” reflects inflammation (“-itis”) of the esophagus with an increased accumulation of eosinophils, a subtype of white blood cells that can contribute to allergic inflammation. The exact causes are not fully understood, but EoE is thought to be linked to immune responses to food allergens and sometimes airborne allergens. EoE can affect patients from infancy through adulthood and is frequently associated with other atopic conditions such as asthma, allergic rhinitis and food allergy. In children, symptoms may include feeding difficulties, food refusal and failure to thrive, while adolescents often experience dysphagia and food impactions that can impact daily life and psychosocial well-being. If left untreated, persistent inflammation may contribute to fibrostenotic esophageal remodeling, resulting in narrowing of the esophagus. References: 1 Summary of Product Characteristics (SmPC) Jorveza ® suspension. 2 Lucendo AJ et al. Budesonide oral suspension is effective and safe for induction therapy of eosinophilic esophagitis in children and adolescents: results from the PEDEOS‑1 trial. UEG Week, 2024. Oral presentation 208. Contact & download press release PDF Dr. Falk Pharma GmbH Dr. Falk Pharma is the expert in digestive and metabolic medicine. As a research-based family business with global presence, we focus on the development and distribution of innovative medicines that improve patients’ health and well-being. Events Reporting adverse events Falsified medicines regulations Social media guidelines © 2026 Dr. Falk Pharma GmbH Imprint Data Privacy Notice × This website is an international information resource intended for healthcare professionals outside the United States (US) and United Kingdom (UK). I am a health care professional outside the US and UK. Close Accept Notice × I confirm I am a UK or Irish resident and have been prescribed either Budenofalk®, Jorveza®, Salofalk® or Ursofalk® I have not been prescribed any of the above medications Accept You are leaving the website of Dr. Falk Pharma. We are not liable for the accuracy of any content published on third party websites - such as the one you are about to be forwarded to. Continue Cancel

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