Eohilia, an Oral Therapy for Eosinophilic Esophagitis, Gets FDA Approval

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02/16/2024

The Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspension) for the treatment of adults and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).

Eohilia is a thixotropic, viscous suspension formulation of the corticosteroid budesonide. These properties allow the suspension to become more fluid when shaken and then return to a viscous state once swallowed. The approval of Eohilia was based on data from 2 double-blind, parallel-group, placebo-controlled 12-week phase 3 trials (Study 1: ClinicalTrials.gov Identifier: NCT02605837; Study 2: ClinicalTrials.gov Identifier: NCT01642212).

Patients were eligible for the studies if they had esophageal inflammation, defined as 15 or greater eosinophils/high-power field (hpf) from at least 2 levels of the esophagus at baseline following a treatment course of a proton pump inhibitor (PPI) either prior to, or during screening, and at least 4 days of dysphagia as measured by the Dysphagia Symptom Questionnaire (DSQ) over a 2-week period prior to randomization. The primary endpoints for both studies were histological remission (defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels) and the absolute change from baseline in patient-reported DSQ combined score after 12 weeks of treatment.

Study 1 included 318 participants (277 adults and 41 children) who were randomly assigned to receive at least 1 dose of Eohilia (n=213) or placebo (n=105). The mean DSQ combined scores at baseline were 30.3 and 30.4 in the Eohilia and placebo groups, respectively. Over 80% were on concomitant PPI therapy. Findings showed 53.1% of the Eohilia group achieved histological remission compared with 1% of the placebo group (treatment difference, 52.4% [95% CI, 43.3-59.1]). The absolute change from baseline in DSQ combined score was -10.2 and -6.5 for the Eohilia and placebo groups, respectively (treatment difference, -3.7 [95% CI, -6.8, -0.6]).

Study 2 included 92 participants (58 adults and 34 children) who were randomly assigned to receive at least 1 dose of Eohilia (n=50) or placebo (n=42). The mean DSQ combined scores at baseline were 30.7 and 29.0 in the Eohilia and placebo groups, respectively. Over 65% were on concomitant PPI therapy. Results showed 38% of Eohilia-treated patients achieved histological remission vs 2.4% of those who received placebo (treatment difference, 35.8% [95% CI, 17.2-50]). The absolute change from baseline in DSQ combined score in the Eohilia vs placebo groups was -14.5 vs -5.9 (treatment difference, -8.6 [95% CI, -13.7, -3.5]).

Additional analysis showed that in the last 2 weeks of both trials, a greater proportion of Eohilia-treated patients experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with placebo. 

After completing the 12-week study, 48 patients from Study 1 were randomly assigned to receive Eohilia 2mg twice daily or placebo for up to an additional 36 weeks. Findings showed Eohilia did not demonstrate statistically significant difference compared with participants re-randomized to placebo based on eosinophil count and/or clinical symptoms (measured by DSQ) at 36 weeks. Based on these findings, the prescribing information for Eohilia notes that the treatment has not been shown to be safe or effective for longer than 12 weeks.

The most common adverse reactions reported with Eohilia were respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.

Eohilia is supplied as a 2mg/10mL cherry-flavored oral suspension in single-dose packs. It should not be taken with food or liquid and patients should wait at least 30 minutes to eat or drink after administration. The product is expected to be available by the end of February.

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