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

Dose-Response and Time-Course Dynamics of Biologics in Eosinophilic Esophagitis: A Model-Based Network Meta-Analysis (ACG 2026) - "Sixteen trial arms across seven classes (dupilumab, cendakimab, mepolizumab, budesonide orodispersible tablet, fluticasone, proton pump inhibitors, and reslizumab) were analyzed. Dupilumab dose-response modeling revealed Emax 88.6%, ED50 1.0 mg, and γ 0.10, indicating near-maximal efficacy at clinical doses with limited gain beyond 100 mg. Increasing from 100 to 300 mg added only 2.3% additional response. Time-course modeling (300 mg weekly) estimated ET50 17.8 weeks, with predicted remission rates of 36% (week 8), 45% (week 12), 62% (week 24), and 80% (week 52), closely matching observed trial data (week 24: 59-60%; week 52: 84.6%)."

Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Dietary Elimination Versus Pharmacological Therapy in Eosinophilic Esophagitis: The Modifying Role of Atopic Comorbidities - A Systematic Review and Meta-Analysis (ACG 2026) - "Thirty-one studies comprising 4,218 patients were included in the quantitative synthesis. Elemental diets achieved the highest histologic remission rate (94.5%), followed by 6-FED (63.9%) and 1-FED (46.4%). Among pharmacological therapies, dupilumab and budesonide orodispersible tablets ranked highest for efficacy."

Retrospective data • Review • Asthma • Atopic Dermatitis • Dermatitis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Respiratory Diseases

EOS-4: Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE (clinicaltrials.gov) - P3 | N=308 | Active, not recruiting | Sponsor: Dr. Falk Pharma GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

LONG-TERM REMISSION OF EOSINOPHILIC ESOPHAGITIS CAN BE ACHIEVED WITH CONTINUOUS BUDESONIDE ORODISPERSIBLE TABLETS BUT NOT WITH AN INTERMITTENT TREATMENT REGIMEN: RESULTS FROM THE PHASE 3 RANDOMIZED CONTROLLED TRIAL EOS-3 (UEGW 2026) - No abstract available

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

THE EOSINOPHILIC ESOPHAGITIS SEVERITY INDEX REFLECTS RESPONSE TO BUDESONIDE ORODISPERSIBLE TABLETS DURING INDUCTION AND MAINTENANCE THERAPY (UEGW 2026) - No abstract available

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

ESOPHAGEAL CANDIDIASIS DURING BUDESONIDE ORODISPERSIBLE TABLET THERAPY FOR EOSINOPHILIC ESOPHAGITIS: REAL-WORLD SAFETY AND EFFICACY DATA (UEGW 2026) - No abstract available

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

EFFICACY OF BUDESONIDE ORODISPERSIBLE TABLETS FOR ESOPHAGEAL STRICTURES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: A SINGLE-CENTER EXPERIENCE (UEGW 2026) - No abstract available

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

The Eosinophilic Esophagitis Severity Index Reflects Response to Budesonide Orodispersible Tablets during Induction and Maintenance Therapy. (PubMed, Clin Gastroenterol Hepatol) - "In BOT-treated EoE, I-SEE reflects multidimensional disease control over time. Higher baseline severity identifies patients with lower response rate to BOT induction and with increased risk of structural complications, supporting early combined medical and endoscopic management."

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Topical Budesonide for Stricture Prevention following Wide-Field Endoscopic Submucosal Dissection of Superficial Esophageal Neoplasia. (PubMed, Visc Med) - "This study evaluated the efficacy and safety of budesonide orodispersible tablets (BOT) for ES prevention after wide-field ESD...BOT prophylaxis was well tolerated and may reduce strictures after non-circumferential resections; however, its protective effect appears limited in circumferential resections. Combination strategies may be warranted in high-risk patients."

Journal • Candidiasis • Esophageal Cancer • Oncology

Maintenance therapy with once or twice daily budesonide orodispersible tablets after budesonide viscous solution in eosinophilic esophagitis. (PubMed, Ther Adv Gastroenterol) - "Similar results were obtained for EoE patients switching maintenance therapy from BVS to BOT 1 mg BID. Maintenance therapy with BOT after BVS may be feasible and effective in the real-world management of EoE patients, with only a numeric increase in the endoscopic suspicion of candidiasis."

Journal • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

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: Mar 2027 ➔ Mar 2028

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

Do we need to endoscopically reassess patients with eosinophilic oesophagitis if they have no symptoms? A prospective real-world cohort study (BSG 2026) - "Adults with confirmed EoE underwent reassessment after ≥8 weeks of stable therapy (food elimination diet, proton pump inhibitor, budesonide orodispersible tablets (BOTs), or combinations). Additional biomarkers beyond eosinophil counts and more sensitive clinical scoring systems are needed. View this table: View inline View popup Abstract P7 Table 1 Clinical and histological outcomes (N=136)"

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

Clinical and Histological outcomes of orodispersible budesonide in adults with eosinophilic oesophagitis at a large UK teaching hospital (BSG 2026) - "Orodispersible budesonide (Jorveza®) has demonstrated efficacy in inducing and maintaining clinico-histological remission in randomised controlled trials, including EOS-1 and EOS-2 and their extension phases...Maintenance therapy was effective in many patients, although loss of response occurred, most commonly with intermittent use. Both once daily and twice daily maintenance regimens appeared effective, supporting the importance of adherence rather than dose selection alone in maintaining remission."

Clinical • Candidiasis • Eosinophilia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Effectiveness of once-daily orodispersible budesonide 1 mg as maintenance therapy in eosinophilic oesophagitis: a pragmatic real-world cohort study (BSG 2026) - "Budesonide orodispersible tablets (BOT) are licensed for induction and maintenance treatment, with current guidance recommending 0.5 mg twice daily for maintenance...Longer follow-up is required to confirm sustained treatment effectiveness. View this table: View inline View popup Abstract P148 Table 1 Clinical and histological outcomes during once-daily 1 mg BOT (n=36)"

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

Budesonide Orodispersible Tablets for Esophageal Lichen Planus. (PubMed, Clin Gastroenterol Hepatol) - No abstract available

Journal • Dermatology • Dermatopathology • Lichen Planus

Low-dose dupilumab as an effective alternative for eosinophilic esophagitis patients with recurrent esophageal candidiasis (EAACI 2026) - "The patient underwent sequential treatments: proton pump inhibitors (PPIs), four-food elimination diet, swallowed fluticasone and budesonide orodispersible tablets. Conclusion Dupilumab, 300 mg every 15 days, appears to be an effective and safe alternative for patients with EoE who achieve remission with STCs but develop recurrent candidiasis. Personalized biologic strategies may provide dual control of esophageal disease and associated respiratory allergic comorbidities."

Clinical • Allergic Rhinitis • Immunology • Inflammation

Treatment patterns of eosinophilic esophagitis in the biologic era-a real-world analysis. (PubMed, Dis Esophagus) - "Although most patients receive STC at the beginning, the majority need multiple treatment lines. Dupilumab is used in a tenth of patients due to refractoriness, side-effects or treatment of other type 2 inflammatory diseases."

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

Efficacy of Biological and Steroid Therapies in Adolescent and Adult Patients with Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis with Meta-regression. (PubMed, Clin Gastroenterol Hepatol) - "All evaluated therapies except etrasimod achieved histologic remission, while only dupilumab, cendakimab, BOS, and BOT were associated with symptomatic improvement in EoE, highlighting dissociations between histologic and symptomatic responses. Most corticosteroid trials were short-term and lacked direct comparisons with biologics. Robust head-to-head trials are needed to define optimal treatment strategies, assess long-term outcomes, and clarify the role of symptom, endoscopic, and histologic endpoints in therapeutic decision-making."

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

Risk factors for oral and esophageal candidiasis during budesonide treatment in eosinophilic esophagitis patients. (PubMed, Intern Emerg Med) - "Eosinophilic esophagitis (EoE) first-line therapy is represented by budesonide orodispersible tablets (BOT), but a very low number of patients develop oral and esophageal candidiasis. The mean eosinophil count before treatment was 45/HPF in patients with candidiasis infection and 33/HPF for the others without. Concomitant PPI therapy and high eosinophilic count may represent risk factors in developing mycosis in EoE patients."

Journal • Candidiasis • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease

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