Eohilia (budesonide oral) / Takeda - LARVOL DELTA

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

FDA REVIEW OF EOHILIA (BUDESONIDE ORAL SOLUTION) FOR TREATMENT OF EOSINOPHILIC ESOPHAGITIS (DDW 2024) - No abstract available

Review • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

SAFETY OF SHORT-TERM THERAPY WITH BUDESONIDE ORAL SUSPENSION FOR EOSINOPHILIC ESOPHAGITIS: AN INTEGRATED SAFETY ANALYSIS OF FOUR PHASE 1–3 CLINICAL STUDIES (DDW 2024) - "ConclusionSafety findings were similar between groups. Short-term BOS was well tolerated and no clinically meaningful concerns were identified supporting future clinical applications of BOS for EoE."

Clinical • P1 data • Candidiasis • Endocrine Disorders • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Pain • Renal Disease

A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Takeda

New P1 trial

FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE) (Businesswire) - "Takeda...announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February....The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 and Study 2)..."

NDA • Eosinophilic Esophagitis • Immunology

Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis. (PubMed, J Pediatr Gastroenterol Nutr) - P2, P3 | "BOS 2.0 mg b.i.d. significantly improved most efficacy outcomes in adolescents with EoE versus placebo."

Clinical • Journal • P2 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE) (Businesswire) - "Takeda...announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus. The resubmission is intended to address previous FDA feedback to the Company’s original NDA submission....Takeda expects a decision from the FDA during the first half of 2024."

NDA • PDUFA date • Eosinophilic Esophagitis • Immunology

Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1-3 clinical trials. (PubMed, Aliment Pharmacol Ther) - P2, P3 | "BOS was well-tolerated; most TEAEs with BOS were mild/moderate in severity."

Journal • P1 data • Eosinophilia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease

Pharmacokinetics of Budesonide Oral Suspension in Children and Adolescents with Eosinophilic Esophagitis. (PubMed, J Pediatr Gastroenterol Nutr) - P2 | "PK parameters were similar between age groups for low- and high-dose BOS, indicating that volume and dose adjustments for age were appropriate for pediatric patients with EoE. BOS was well tolerated."

Clinical • Journal • PK/PD data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pediatrics

EFFECT OF RANDOMIZED WITHDRAWAL OF BUDESONIDE ORAL SUSPENSION ON EFFICACY IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: POST HOC ANALYSIS OF HISTOLOGIC, SYMPTOM AND ENDOSCOPIC OUTCOMES (DDW 2022) - P3 | "Methods This post hoc analysis used data from the phase 3 36-week study (SHP621-302; NCT02736409), which followed the phase 3 12-week study (SHP621-301; NCT02605837) of BOS 2.0 mg twice daily (b.i.d.) in patients 11–55 years old with EoE and dysphagia...Conclusion sOverall, more BOS–PBO than BOS–BOS patients relapsed over 36 weeks, as determined by a more clinically relevant post hoc relapse definition. Using LOCF, improvements in histologic, symptom, clinicopathologic and endoscopic outcomes were greater for BOS–BOS than BOS–PBO patients."

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

Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE) (clinicaltrials.gov) - P3 | N=133 | Terminated | Sponsor: Shire | Active, not recruiting ➔ Terminated; Sponsor decision

Trial termination • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Update on Emerging Pharmacologic Therapies for Patients With Eosinophilic Esophagitis. (PubMed, Gastroenterol Hepatol (N Y)) - "Some newer topical corticosteroid preparations are being studied, including a budesonide suspension (TAK-721), orodispersible tablet formulations of budesonide and fluticasone (APT-1011), and mometasone and ciclesonide preparations. Also in various stages of clinical trials are potential disease-modifying biologics such as dupilumab, cendakimab, lirentelimab, benralizumab, and mepolizumab. Some of these medications have proven efficacious for other atopic conditions and show incredible promise for the treatment of eosinophilic gastrointestinal diseases. Further studies will be needed to determine long-term treatment outcomes for each of these drugs."

Journal • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology

Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721 (Takeda Press Release) - "Takeda Pharmaceutical...today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus....The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form."

FDA event • Eosinophilic Esophagitis • Immunology

"With Sanofi's mighty Dupixent chasing behind, Takeda's Eohilia suffers FDA rejection after mysterious delay https://t.co/niuak6o4R2" (@FiercePharma)

FDA event

". @TakedaPharma suffers a setback in its Wave1 set of blockbuster hopefuls after FDA turns down TAK-721 for eosinophilic oesophagitis #Pharma https://t.co/n6Sh1xHV3z" (@pharmaphorum)

Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology