Takeda received approval from the U.S. FDA for EOHILIA (budesonide oral suspension), the first and only approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL single-dose stick packs by the end of February.
 
EOHILIA is a corticosteroid indicated for 12 weeks of treatment. Developed specifically for EoE, its novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed.
 
The FDA approval is based on efficacy and safety data from two multicenter, randomized, double-blind, placebo-controlled studies in patients with EoE. Efficacy endpoints included histologic remission and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported by patients.
 
Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%). In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group. Absolute change from baseline in DSQ combined score in the EOHILIA vs. placebo groups in Study 1 was -10.2 vs. -6.5 and in Study 2, -14.5 vs. -5.9. During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo.
 
EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus.4 Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. The chronic inflammation of EoE can lead to a range of symptoms, and include difficulty swallowing, vomiting and pain.