Jorveza (budesonide orodispersible tablets) / Dr Falk - LARVOL DELTA

EOS-4: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (clinicaltrials.gov) - P3 | N=308 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Trial completion date: Dec 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2026 ➔ Dec 2026

Head-to-Head • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Dose reduction of budesonide in eosinophilic oesophagitis: is less enough ? (BWG 2026) - "Introduction: Budesonide Orodispersible Tablets (BOT) are highly effective in the treatment of eosinophilic oesophagitis (EoE)... Dose reduction of BOT 1mg BID to 1mg OD is clinically feasible as maintenance therapy for EoE, with only few patients losing histological remission and overall lower rates of Candida. However, the subtle increase in peak eosinophils and severity scores suggest that a longer follow-up is needed to detect potential loss of response beyond 6 months. References: 1."

Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Jorveza. (European Medicines Agency) - "The CHMP adopted a new pharmaceutical form, oral suspension, with a new strength, 0.2 mg/ml, associated with a new indication as follows: 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." "

CHMP • Eosinophilic Esophagitis

INTERMITTENT OR CONTINUOUS THERAPY WITH BUDESONIDE ORODISPERSIBLE TABLET FOR MAINTENANCE OF REMISSION IN EOSINOPHILIC ESOPHAGITIS: RESULTS FROM A RANDOMIZED, CONTROLLED PHASE 3 TRIAL (DDW 2026) - No abstract available

Clinical • P3 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

BUDESONIDE ORODISPERSIBLE TABLET IS SUPERIOR TO PANTOPRAZOLE IN PATIENTS WITH EOSINOPHILIC EOSPHAGITIS PRESENTING INTIALLY WITH FOOD BOLUS IMPACTION:A RANDOMISED CONTROLLED TRIAL (DDW 2026) - No abstract available

Clinical • Eosinophilic Esophagitis

Real-world experience of budesonide orodispersible tablets in pediatric eosinophilic esophagitis. (PubMed, J Pediatr Gastroenterol Nutr) - "After a median follow-up of 12.5 months (6.25-21 IQR), 11/17 (65%) patients were still on BOT treatment, and 9/11 (82%) were in clinical remission. No adverse events were reported."

Journal • Real-world evidence • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Pediatrics

EOS-4: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (clinicaltrials.gov) - P3 | N=308 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Sep 2026

Head-to-Head • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Randomised trial of Budesonide Orodispersible tablet (BOT) at 2mg orally once daily compared to 1mg orally once daily in patients with Eosinophilic oesophagitis (EoE) who initially respond to Budesonide 1mg orally twice daily. (ANZCTR) - P4 | N=72 | Not yet recruiting | Sponsor: Northern Adelaide Local Health Network

New P4 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Comparative Efficacy and Safety of Swallowed Topical Corticosteroids in Eosinophilic Esophagitis: A Network Meta-Analysis. (PubMed, J Clin Med) - " Budesonide orodispersible tablets were the best option for achieving EoE histological remission, but not symptomatic or endoscopic improvement. STC formulations were as safe as placebo or PPI."

Journal • Retrospective data • Review • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

PROSPECTIVE MULTICENTRE EVALUATION OF THE I-SEE SCORE FOR MONITORING DISEASE ACTIVITY IN ADULTS WITH EOSINOPHILIC ESOPHAGITIS TREATED WITH BUDESONIDE ORODISPERSIBLE TABLETS (UEGW 2025) - "In this prospective observational study, the application of the recently developed I-SEE score for EoE assessment confirms the high efficacy of the treatment of BOT. However, baseline I-SEE score calculation was not useful in predicting nor stratifing patients' response to drug therapy. Further studies are necessary to outline the weighted scoring of each feature involved into score calculation."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

REFRACTORY LICHEN PLANUS ESOPHAGITIS TREATED WITH BUDESONIDE ORODISPERSIBLE TABLETS: A CASE REPORT (UEGW 2025) - "Clinical Case Summary: A 53-year-old woman was diagnosed with a severe eosinophilic esophagitis showing poor response to multiple therapies, such as high dose of proton pump inhibitors, oral, topical (swallowed fluticasone) and systemic steroids. Esophageal involvement (LPE) is frequently an underrecognized condition but bears important therapeutic implications, due to its chronic and relapsing tendency, and may have malignant potential[1].Endoscopy and tailored long term therapy remain crucial. We suggest BOT as a viable treatment option for LPE."

Case report • Clinical • Dermatology • Dermatopathology • Endocrine Disorders • Eosinophilic Esophagitis • Gastrointestinal Disorder • Hepatology • Immunology • Lichen Planus

EFFICACY AND SAFETY OF LONG-TERM TREATMENT WITH BUDESONIDE ORODISPERSIBLE TABLETS IN PATIENTS WITH EOE: REAL-LIFE DATA FROM A SINGLE-CENTRE EXPERIENCE (UEGW 2025) - "On the basis of our results, BOT therapy is effective in the induction and maintenance of histological remission in EoE. BOT monotherapy and a history of GERD are risk factors for the development of erosive esophagitis after BOT induction and maintenance, respectively. These findings suggest the need for a more personalized treatment approach and highlight the potential role of BOT-PPI combination therapy in selected cases."

Clinical • Candidiasis • Eosinophilic Esophagitis • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Immunology

TREATMENT PATTERNS IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS IN ERA OF BIOLOGICS – A MULTI-CENTRE RETROSPECTIVE STUDY (UEGW 2025) - "Despite being studied for years, the EoE-specific therapy has been approved only recently and includes budesonide orodispersible tablet (1) and IL-4R antagonist, dupilumab (2). This is the first study on different therapy courses in patients with EoE in Europe. Due to its retrospective character, no direct conclusions on the superiority of one approach upon another in case of refractoriness are possible."

Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • IL4R

PREDICTORS OF RESPONSE TO BUDESONIDE ORODISPERSIBLE TABLETS INDUCTION THERAPY IN ADULT EOSINOPHILIC ESOPHAGITIS: A RETROSPECTIVE SINGLE-CENTER STUDY (UEGW 2025) - "Patients presenting with food impaction requiring emergency gastroscopy may be less likely to respond to induction therapy with BOT, potentially due to a more advanced stage of EoE. Moreover, patients with prior PPI use also seem to have a reduced likelihood of therapeutic response, possibly due to symptom masking and consequent diagnostic delay, ultimately reducing treatment effectiveness."

Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EFFICACY OF BUDESONIDE ORODISPERSIBLE TABLETS ON ESOPAGHEAL STENOSIS IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: A SINGLE CENTRE EXPERIENCE (UEGW 2025) - "Esophageal strictures in EoE are a well-known complication of disease. Our results show that stenosis may be modified by BOT induction therapy with a total remission or improvement in diameter in most of patients. This data could be explained by the inflammatory component of some stenosis, which respond to medical therapy with budesonide."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

ONE PILL A DAY KEEPS EOSINOPHILIC OESOPHAGITIS AWAY? MAINTENANCE TREATMENT WITH BUDESONIDE ORODISPERSIBLE TABLETS OR VISCOUS SOLUTION (UEGW 2025) - "Treatment with BOT after switching from BVS is feasible and highly effective in EoE patients. The increase in candidiasis with BOT has been linked to treatment response and adherence in EoE (2). A longer follow-up of maintenance therapy with BOT is ongoing."

Clinical • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EFFICACY OF BUDESONIDE ORODISPERSIBLE TABLET SPLIT VERSUS SINGLE DOSE FOR MAINTENANCE OF REMISSION IN EOSINOPHILIC ESOPHAGITIS: TOTAL DAILY DOSE MAY MATTER MORE THAN THE ADMINISTRATION FREQUENCY (UEGW 2025) - "Persistent clinical endoscopic, and histological remission was maintained in most patients treated either with BOT 1mg od or BOT 0.5mg bid for a median of 20 weeks, indicating that the total daily dose of BOT 1mg may be more important that the frequency of administration, at least in the short term.Patients' data on maintenance treatment0.5mg bid (n = 28)1mg od (n = 28)p-valueMaintenance treatment duration before biopsy collection (weeks)20 (12 - 32)20 (12 - 36)>0.9Eosinophil counts per high-power field0 (0 - 2)1 (0 - 3)0.5EREFS on maintenance treatment1.00 (0.00 - 2.00)1.00 (0.00 - 2.00)0.8ISEE-Total (0-40)3.00 (2.00 - 4.00)3.00 (2.00 - 4.00)0.5EOEHSS STAGE0.50 (0.00 - 1.00)0.00 (0.00 - 1.00)0.3EoEHSS GRADE0.00 (0.00 - 1.00)1.00 (0.00 - 1.25)0.06PiEAQ on maintenance treatment0.50 (0.00 - 2.00)1.50 (0.75 - 2.00)0.06Abnormal DSQ post treatment (>30% compared to baseline)2 (7.1%)4 (14%)0.7Histological recurrence while on maintenance treatment2 (7.1%)4 (14%)0.7"

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

LONG-TERM EFFECTIVENESS AND SAFETY OF ORODISPERSIBLE BUDESONIDE FOR THE TREATMENT OF EOSINOPHILIC ESOPHAGITIS: A MULTICENTRE REAL-WORLD STUDY (UEGW 2025) - "Recently, a novel formulation of budesonide orodispersible tablet (BOT) has become available, showing a high efficacy in randomised placebo-controlled trials... This study confirms the effectiveness of the treatment with BOT in both inducting and maintaining remission of EoE in a real-life setting, either considering clinical, endoscopic and histologic outcomes. Our data also showed a good safety profile, with a few patients requiring drug interruption."

Clinical • Real-world • Real-world evidence • Candidiasis • Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology

THE PISA EOE ADAPTATION QUESTIONNAIRE FOR ADAPTIVE BEHAVIORS ACCURATELY MONITORS HISTOLOGICAL DISEASE ACTIVITY TRENDS FOLLOWING TREATMENT IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS : A PROSPECTIVE, LONGITUDINAL STUDY (UEGW 2025) - "Following treatment with budesonide orodispersible tablets (72.2%), PPIs (19.6%), dupilumab (5.5%), or milk-free diet (2.7%), histological remission was achieved in 78.4% of patients, while 21.6% remained histologically active. The PiEAQ is the first questionnaire investigating adaptive behaviors as a standalone domain in EoE. We demonstrated that longitudinal variations in PiEAQ scores are sensitive to HDA variations over time and can monitor histological disease activity trends after treatment. This study confirms that, similar to dysphagia, adaptive behaviors contribute to disease burden in EoE and improve with treatment.GroupPiEAQ baseline(median)PiEAQ post-treatment(median)∆PiEAQ (T1-T0)p-valueNon-responder (n=8)21.86-0.140.3Responder (n=29)1.960.138-1.83<0.0001GroupmDSQ baseline(median)mDSQ post-treatment(median)∆mDSQ (T1-T0)p-valueNon-responder (n=8)2.292+0.160.8Responder (n=29)3.270.33-2.92<0.0001GroupEHAS baseline(median)EHAS post-treatment(median)∆EHAS..."

Clinical • Longitudinal study • Observational data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Mood Disorders • Psychiatry

Effectiveness and Safety of Orodispersible Budesonide for Eosinophilic Esophagitis: A Multicenter Real-World Study. (PubMed, Clin Gastroenterol Hepatol) - "Our real-world data confirm that BOTs are effective in inducing clinical and histologic remission in most EoE patients. The drug has a good safety profile, with side effects occurring only in a small number of patients."

Clinical • Journal • Real-world evidence • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

EOS-4: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (clinicaltrials.gov) - P3 | N=308 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Mar 2026

Head-to-Head • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

'Insights into lymphocytic oesophagitis: a retrospective review of patient data' (BSG 2025) - "All patients received high dose of PPI and 9 patients received topical steroids (budesonide orodispersible tablets (8/9) and Fluticasone inhalers (2/9)). There may be an association between lymphocytic oesophagitis and autoimmune diseases, drug allergy, smoking and excess alcohol consumption. Most patients response to high dose PPI, with topical steroids as a second line treatment showing variable success."

Retrospective data • Review • Dermatology • Endocrine Disorders • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain • Psoriasis

Cost-utility analysis of sequential therapies for pediatric-onset eosinophilic esophagitis. (PubMed, J Pediatr Gastroenterol Nutr) - "BOT and CM-starting step-up ED are present in both effective and cost-effective sequential treatments for EoE. The option PPI-BOT-ED(CM)-DUP succeeded in approaching the most effective alternative while balancing costs."

HEOR • Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pediatrics

Real-World Effectiveness of Budesonide Orodispersible Tablets for Eosinophilic Oesophagitis: The Importance of Patience and Education. (PubMed, Aliment Pharmacol Ther) - "Adverse events were reported by 16% of patients and 17% were noted to have incorrect technique of administration. BOT was demonstrated to have lower rates of clinicohistological remission in real-world practice than reported in clinical trials, largely due to incorrect technique and cessation due to adverse events."

Journal • Real-world evidence • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

The crucial role of allergists in the clinical management and treatment of eosinophilic esophagitis. (PubMed, Eur Ann Allergy Clin Immunol) - "Recently new drugs, such as budesonide orodispersible tablets and a monoclonal antibody targeting interleukin-4 and 13, have been found to be effective in clinical trials and approved to treat this condition. A prompt diagnosis and correct management of these patients is of paramount importance to prevent fibrostenosis of the oesophagus and to improve the quality of life. The complex management of patients living with EoE requires the integrated cooperation of several specialists, including allergists, gastroenterologists, pathologists, dietitians, and psychologist."

Journal • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • IL4