Eohilia (budesonide oral) / Takeda - LARVOL DELTA

Real-World Utilization of Budesonide Oral Suspension in Patients With Eosinophilic Esophagitis Shows Use Beyond 12 Weeks: A Retrospective Cohort Study of US Health Insurance Claims Data (ACG 2026) - "Among 339 patients with EoE receiving BOS (mean age: 36.7 years; 63.7% male; 96.2% commercial insurance), the mean (standard deviation [SD]) number of claims for BOS was 2 (1.5) per patient (maximum, 18). Mean (SD) total number of days supplied for BOS was 67.9 (53.4) with a mean supply of 35.5 (16.4) days per prescription. Overall, 50/339 (14.7%) patients restarted BOS after a mean (SD) of 69.9 (40.1) days."

Real-world • Real-world evidence • Reimbursement • Retrospective data • US reimbursement • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Missed Opportunities for Diagnosis and Treatment of Eosinophilic Esophagitis Following Acute Food Impaction and Dysphagia Events in the USA (ACG 2026) - "In the 3 months after the index event, 76.9% of those with newly diagnosed EoE received pharmacologic treatment; proton-pump inhibitors (PPIs) were most common (73.8%), followed by off-label corticosteroids (13.1%), and only a small proportion received FDA-approved treatments (dupilumab [1.2%] or budesonide oral suspension [0.8%])... Overall, 245,100 patients with â¥1 food impaction and/or dysphagia event were identified. In the 12 months before the index event, 2170 (0.9%) had a claim for EoE (i.e. had established EoE) and 239,713 (97.8%) did not (i.e."

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Insurance Coverage and Patient Out-of-Pocket Costs Influence Physicians in Choosing Off-Label Over FDA-Approved Treatments for Patients With Eosinophilic Esophagitis: Results From a U.S. Physician Survey (ACG 2026) - "PPIs were dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole and vonoprazan (although vonoprazan is not a PPI, it is a potassium-competitive acid blocker and is included as part of this group for the purposes of this survey); â For example, elemental diet, 6-/4-/2-food elimination diet; â¡Off-label swallowed topical corticosteroids were inhaled budesonide and fluticasone propionate formulations that are swallowed, rather than inhaled (off-label use); §Systemic corticosteroids were betamethasone, hydrocortisone and prednisone. In total, 100 physicians completed the survey (gastroenterologists, 36%; allergists/immunologists, 35%; primary care providers, 29%); the majority had been practicing for >15 years. Proton-pump inhibitors (PPIs), dietary intervention and off-label swallowed topical corticosteroids were the most common first-line treatments for adults with EoE. FDA-approved treatments, BOS and dupilumab, were..."

Clinical • Reimbursement • US reimbursement • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Real-World Clinical Efficacy of Food and Drug Administration-Approved Budesonide Oral Suspension Across Histologic, Endoscopic, and Symptomatic Outcomes. (PubMed, Gastro Hep Adv) - "Symptoms and endoscopic findings improved in parallel. Because the majority of prescriptions could be filled and significant improvement was achieved compared to prior treatments, BOS should be considered when topical steroids are selected for EoE."

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

Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis. (clinicaltrials.gov) - P1 | N=60 | Enrolling by invitation | Sponsor: Mayo Clinic | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology

Dupilumab Failures in Pediatric and Adolescent Eosinophilic Esophagitis: A Retrospective Cohort Study (AAAAI 2026) - "Remaining non-responders transitioned to one of the following: increased dose of dupilumab, combination dupilumab/ swallowed corticosteroids, Eohilia alone, or enrollment in tezepelumab trial; all with re-analysis pending. However, there is subset of EoE patients with persistent disease despite symptom improvement. Further work is needed to define/predict non-responders and improve personalized approaches to treatment."

Retrospective data • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology • Pediatrics

Effect of Budesonide Oral Suspension on Time to First Dysphagia Symptom Response and Dysphagia Symptom Resolution Outcomes in Patients With Eosinophilic Esophagitis. (PubMed, J Gastroenterol Hepatol) - P2, P3 | "BOS is efficacious in managing dysphagia in EoE across several symptom metrics."

Clinical • Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis. (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Mayo Clinic

New P1 trial • Eosinophilic Esophagitis • Fibrosis • Gastrointestinal Disorder • Immunology

Prior Nonresponders To Off-label Corticosteroids Can Respond To Budesonide Oral Suspension Treatment for Eosinophilic Esophagitis (ACAAI 2025) - P3 | "We examined whether histologic nonresponders to OLCs responded when switched to budesonide oral suspension (BOS/Eohilia), an FDA-approved, EoE-specific formulation...Patients’ prior use of OLCs (oral viscous budesonide, swallowed fluticasone aerosol and/or systemic [oral] corticosteroids) and histologic response to these treatments (<15 or ≥15 eosinophils per high-power field [eos/hpf]) were obtained from study records...Conclusion A notable proportion of patients responded to BOS, despite prior non-response to OLCs. These findings support BOS as a first-line treatment option for EoE, and also for OLC nonresponders."

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Treatment Patterns In Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension In The USA (ACAAI 2025) - "Abstract Introduction Budesonide oral suspension (BOS/Eohilia), a swallowed corticosteroid, was approved for eosinophilic esophagitis (EoE) by the FDA in February 2024. Compared with those receiving OLCs or dupilumab, a numerically greater proportion of BOS-treated patients had dysphagia and food obstruction before treatment initiation and had received prior EoE treatment (Table). Conclusion These data suggest that BOS-treated patients may be more likely to have had dysphagia and food obstruction before treatment initiation than those receiving other index therapies; BOS was prescribed most often by gastroenterologists."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Effect of Social Determinants of Health on Healthcare Costs and Access to Care in Patients With Eosinophilic Esophagitis: A Retrospective Cohort Study of US Health Insurance Claims Data (ACG 2025) - "Overall, 40,619 patients diagnosed with EoE were included (ICC, n=26,340; MFFS, n=14,279). Patient demographics (ICC and MFFS): mean (SD) age at index, 38.0 (16.8) and 67.0 (13.1) years; male, 58.8% and 50.4%. For both ICC and MFFS, patients diagnosed with EoE living in urban/suburban areas were diagnosed significantly more quickly than those living in rural areas (ICC, by 36.5 days, p< 0.001; MFFS, by 32.9 days, p=0.02 (Table 1)."

HEOR • Reimbursement • Retrospective data • US reimbursement • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology

13160: Taking a Deep Dive Into Eohilia, an Oral Therapeutic Option (DDW 2025) - "Description: Join our discussion as we look at answering an unmet need in pediatric and adult patients with Eosinophilic Esophagitis (EoE) through an oral therapeutic option, EOHILIA (budesonide oral suspension). EOHILIA is a ready-to-use oral suspension that was designed specifically for EoE."

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pediatrics

TAKING A DEEP DIVE INTO EOHILIA, AN ORAL THERAPEUTIC OPTION (DDW 2025) - "Supported by: Takeda Pharmaceuticals U.S.A., Inc."

EFFECT OF DISEASE SEVERITY ON HISTOLOGIC, DYSPHAGIA SYMPTOM AND ENDOSCOPIC OUTCOMES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: POST HOC ANALYSIS FROM A PHASE 3 TRIAL OF BUDESONIDE ORAL SUSPENSION (DDW 2025) - P3 | "Discussion BOS was more efficacious than placebo for histologic and endoscopic outcomes in patients with moderate or severe EoE; positive trends were observed for dysphagia symptom outcomes. These data support the efficacy of BOS in managing EoE across the disease severity spectrum."

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

Long-Term Safety and Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis: a 4-Year, Phase 3, Open-Label Study. (PubMed, Clin Gastroenterol Hepatol) - "Long-term treatment with BOS was well tolerated. Despite dosing changes/interruptions, approximately half of patients achieved/maintained a histologic response; initial improvements in endoscopic outcomes were maintained over 48 months."

Journal • P3 data • Candidiasis • Endocrine Disorders • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Nephrology • Renal Disease

Effect Of Randomized Treatment Withdrawal Of Budesonide Oral Suspension On The Durability Of Dysphagia Symptom Improvement In Patients With Eosinophilic Esophagitis: A Post Hoc Analysis Of A Phase 3, 36-Week Trial (AAAAI-WAO 2025) - P3 | "Methods Patients aged 11–55 years with EoE who had a clinicopathologic response (≤6 eosinophils per high-power field and ≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] score from baseline) after 12 weeks of BOS 2.0 mg twice daily during SHP621-301 (NCT02605837) were randomized (1:1) to continue BOS (BOS–BOS) or withdraw to placebo (BOS–placebo [PBO]) for up to 36 weeks during SHP621-302 (NCT02736409)...Conclusions A quarter of patients maintained a dysphagia symptom improvement following BOS withdrawal (i.e. did not relapse), and a median duration of 8.4 weeks was observed between BOS withdrawal and dysphagia symptom relapse. This suggests symptom improvements following 12 weeks of BOS therapy can be maintained after treatment cessation in some patients."

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

Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis. (PubMed, Therap Adv Gastroenterol) - P3 | "Using LOCF, more BOS-BOS than BOS-PBO patients also maintained or had improvements in efficacy endpoints. ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT02605837, NCT02736409."

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

Effect of Esophageal Dilation History on Efficacy Outcomes in Patients With Eosinophilic Esophagitis Receiving Budesonide Oral Suspension. (PubMed, Am J Gastroenterol) - P3 | "Esophageal dilation history may confound the association between histologic outcomes and dysphagia symptom or endoscopic efficacy outcomes in patients with EoE receiving swallowed corticosteroids."

Clinical • Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Pharmacologic Treatment of Eosinophilic Esophagitis: Efficacious, Likely Efficacious, and Failed Drugs. (PubMed, Inflamm Intest Dis) - "Before the approval of Jorveza® and Eohilia®, several investigator-initiated randomized controlled clinical studies evaluated esophagus-targeted formulations of either budesonide or fluticasone to treat pediatric and adult EoE patients...Dupilumab (Dupixent®), a monoclonal antibody targeted against IL-4 and IL-13, was approved by regulatory authorities in the USA, Europe, Canada, but not yet Australia...Due to lack of efficacy or unfavorable safety profile, the following drugs are not recommended for EoE treatment: systemic steroids, sodium cromoglycate, montelukast, azathioprine, TNF-antagonists (e.g., infliximab), vedolizumab (mAb against α4β7), benralizumab (mAb against IL-5 receptor), mepolizumab (mAb against IL-5), reslizumab (mAb against IL-5), omalizumab (mAb against IgE), and lirentelimab (mAb against Siglec-8). Long-term effectiveness and safety data on different drugs are currently sparse. Concerted efforts of different stakeholders will be..."

Journal • Review • Eosinophilic Esophagitis • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • Pediatrics • IL13 • IL4 • IL5 • SIGLEC8

Effect of Budesonide Oral Suspension on Dysphagia Symptom Resolution and Time to First Dysphagia Symptom Response in Eosinophilic Esophagitis: Post Hoc Analysis of Phase 2 and Phase 3 Placebo-Controlled Trials (ACG 2024) - P2, P3 | "Overall, 415 patients from MPI 101-06 (BOS, n = 51; placebo, n = 42) and SHP621-301 (BOS, n = 215; placebo, n = 107) were included. At all time points, more BOS- than placebo-treated patients had complete dysphagia symptom resolution or reported dysphagia but had no daily score greater than 0 for Q3 and Q4 ( Table ). BOS-treated patients had greater LS mean increases from baseline in the number of dysphagia-free days than placebo-treated patients at all time points."

Clinical • P2 data • P3 data • Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

Effect of Budesonide Oral Suspension on Dysphagia Symptom Outcomes in Patients With Eosinophilic Esophagitis: A Pooled Post Hoc Analysis of Data From a Phase 2 and a Phase 3 Trial (ACG 2024) - P2, P3 | " This post hoc analysis pooled data from a phase 2 (MPI 101-06; NCT01642212) and a phase 3 (SHP621-301; NCT02605837) study of BOS 2.0 mg b.i.d... Overall, 410 patients were included (BOS, n = 263; placebo, n = 147). Most patients were male and White. Mean (SEM) prorated 14- and 7-day DSQ scores were similar for BOS- and placebo-treated patients at baseline (14-day: BOS = 30.5 [0.9], placebo = 30.0 [1.1]; 7-day: BOS = 15.2 [0.5], placebo = 14.7 [0.6])."

Clinical • P2 data • P3 data • Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EFFECT OF BUDESONIDE ORAL SUSPENSION ON DYSPHAGIA SEVERITY OUTCOMES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (ACAAI 2024) - P2, P3 | "These findings suggest that BOS improves dysphagia severity as early as week 4 of treatment. Table. Dysphagia severity outcomes at weeks 4, 8 and 12 of treatment for patients with EoE who received BOS 2.0 mg b.i.d."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Budesonide Oral Suspension in Healthy Adult Participants: A Randomized Phase 1 Study. (PubMed, J Clin Pharmacol) - "Safety and tolerability were also assessed throughout the study; all adverse events were mild or moderate in severity. Despite slight differences in budesonide PK parameters between fed and fasting conditions, the effect of food on systemic exposure to budesonide (BOS formulation) is not expected to be clinically meaningful."

Journal • P1 data • PK/PD data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Budesonide oral suspension (Eohilia) for eosinophilic esophagitis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

11105: Product Theater: What's Next in EoE: Taking a Deep Dive into a New Therapeutic Option (DDW 2024) - "EOHILIA is a ready-to-use oral suspension that was designed specifically for EoE. Sponsored by Takeda Pharmaceuticals U. S. A. , Inc."

Eosinophilic Esophagitis • Pediatrics