FDA Approves First Oral Option for Eosinophilic Esophagitis

The FDA approved budesonide oral suspension (Eohilia) for adults and children ages 11 years and older with eosinophilic esophagitis (EoE), drugmaker Takeda announced.

Approval of the 12-week course of corticosteroids, delivered as a 2-mg dose twice daily, was based on data from two randomized trials involving EoE patients ages 11 to 56 years.

In both, significantly more patients on budesonide achieved histologic remission compared with those on placebo (53.1% vs 1% in Study 1; and 38% vs 2.4% in Study 2), with remission defined as a peak of ≤6 eosinophils per high-powered field.

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options,” explained investigator Ikuo Hirano, MD, director of the Kenneth C. Griffin Esophageal Center at Northwestern University Feinberg School of Medicine in Chicago, in a statement.

“With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” said Hirano. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that Eohilia offers as an oral medication.”

Budesonide oral suspension joins injectable dupilumab (Dupixent) as the only approved drugs for EoE, a chronic disease characterized by esophageal inflammation that can result in choking, vomiting, and painful or difficulty in swallowing. The immune-mediated condition has no known cause, but certain foods and environmental allergens have been implicated.

Diagnosis is difficult and often delayed in patients, but esophageal narrowing can occur if left untreated and increase the risk for food impaction.

In terms of symptoms, both of the multicenter studies showed greater improvement after 12 weeks of oral budesonide when it came to absolute change from baseline on the combined score of the patient-reported Dysphagia Symptom Questionnaire (DSQ):

• -10.2 vs -6.5 with placebo in Study 1
• -14.5 vs -5.9, respectively, in Study 2

The DSQ assesses patients’ degree of swallowing difficulty and their behavioral adaptations due to EoE. During the last 2 weeks on study, patients on the corticosteroid were less likely to experience dysphagia and were more likely to say dysphagia was improving or cleared up.

In Study 1, adverse events (AE) occurring more frequently with budesonide included respiratory tract infections in 13%, gastrointestinal mucosal candidiasis in 8%, headache in 5%, gastroenteritis in 3%, throat irritation in 3%, adrenal suppression in 2%, and erosive esophagitis in 2%. AEs were described as being similar in Study 2, and Takeda noted that the safety and efficacy of the product for EoE has not been established beyond 12 weeks.

According to the drug’s label, budesonide oral suspension is contraindicated in those with hypersensitivity to the corticosteroid as serious reactions including anaphylaxis have occurred. Warnings and precautions include sections on hypercorticism and adrenal axis suppression, increased risks of infection, erosive esophagitis, potential effects on growth, steroid withdrawal and other corticosteroid effects, and recurrence of Kaposi’s sarcoma.

The drug is not recommended during pregnancy and for people with severe liver impairment, and concomitant use with CYP3A4 inhibitors should be avoided, according to the prescribing information.

The product comes in single-dose stick packs (2 mg/10 mL), and Takeda said it expects the drug to be available by the end of the month.

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