FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis

The FDA has approved Takeda’s Eohilia (budesonide), an 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.

Eosinophilic esophagitis is an inflammatory disease of the esophagus, causing it to narrow and develop abscesses. 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, which can vary by person and age, and include difficulty swallowing, vomiting and pain.

Eohilia is a corticosteroid indicated for 12 weeks of treatment. It is a liquid formulation of budesonide and will have a wholesale acquisition cost of $1,875 per month. Takeda offers services to provide access support, including the Eohilia Patient Support and Copay Program. Commercially insured patients may be eligible to pay as little as $0. For eligible patients, Eohilia will be part of a Takeda Patient Assistance Program. A spokesperson indicated the company is working to ensure access for as many appropriate patients as possible.

The FDA approval of Eohilia is based on efficacy and safety data from two multicenter, randomized studies in patients — ages 11 to 56 in study one and 11 to 42 in study two. In both studies, patients received at least one dose of either Eohilia 2 mg or placebo orally twice daily.

Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in study one (53.1% vs. 1%). In study two, 38% of Eohilia patients achieved histologic remission vs. 2.4% of those in the placebo group

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

The FDA had issued a complete response letter for Eohilia in December 2021 and suggested Takeda conduct an additional trial. Takeda had resubmitted its application in September 2023. At the time, the company said it had reanalyzed clinical data and worked with regulators for a revised indication, for short-term treatment of EoE.