Takeda Pharmaceutical Company 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 individuals aged 11 years and older with eosinophilic esophagitis (EoE). EOHILIA, a corticosteroid, is indicated for a 12-week treatment period and features a novel formulation that enhances its effectiveness in treating EoE. The approval is based on two multicenter, randomized, double-blind, placebo-controlled studies, which demonstrated significant improvements in both histologic remission and patient-reported Dysphagia Symptom Questionnaire (DSQ) scores.
Key Insights
- Innovative Drug Formulation: EOHILIA’s unique thixotropic properties, which change in viscosity during administration, represent a significant advancement in drug delivery for EoE treatment.
- Impact on EoE Management: The approval of EOHILIA offers a new, effective oral treatment option for EoE, potentially improving the quality of life for patients suffering from this condition.
- Clinical Trial Success: The positive outcomes from the clinical trials underscore the potential of EOHILIA in effectively managing EoE symptoms and reducing esophageal inflammation.
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