FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis


The FDA approval marks the first and only FDA-approved oral therapy for this patient population, and the drug is expected to be available by the end of February.

The FDA approved budesonide oral suspension (Eohilia; Takeda) for the treatment of eosinophilic esophagitis (EoE) for 12 weeks of treatment in patients aged 11 years and older, making it the first and only FDA-approved oral therapy for this patient population. It is expected to be available by the end of February in 2 mg/10 mL single-dose stick packs, according to a press release.

Blue stamp on a glittering background: FDA approved background | Image Credit: Argus - stock.adobe.com

Argus - stock.adobe.com

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options,” Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine, said in the press release. With [budesonide], 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.”

About the ORBIT 2 Study

Trial Name: An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) (ORBIT2)

ClinicalTrials.gov ID: NCT02736409

Sponsor: Shire

Completion Date: November 2019

The approval for budesonide is based on efficacy and safety data from 2 randomized double-blinded 12-week studies for patients aged 11 to 56 years and 11 to 42 years in their respective studies. Individuals received at least 1 dose of budesonide 2 mg twice daily or the placebo at the same intervals. Histologic remission, including peak eosinophil count of 6 or less per high-powered field in all available esophageal levels, and the absolute change from baseline based on Dysphagia Symptom Questionnaire (DSQ), which measures how often the patient has trouble swallowing and behavioral adaptions after use, combined score after 12 weeks of treatment, according to the press release.

In the study, investigators found that more individuals achieved histological recommission at 53.1% compared to the placebo at 1% in the first study, and 38% and 2.4%, respectively, in study 2. The absolute change from baseline in study 1 was -10.2 in the treatment group and -6.5 for the placebo and -14.5 and -5.9, respectively, in study 2, according to the press release.

According to the press release, in the last 2 weeks of the study, more patients who were taking the treatment had either no dysphagia or only experienced dysphagia that either got better or cleared up on its own compared to the placebo. The drug has not been shown to be safe or effective for more than 12 weeks in this indication.

“For most of us, eating is a simple experience. But for [those] living with [EoE], sitting down for a meal can include painful and difficult swallowing, chest pain, and a choking sensation,” Brandon Monk, senior vice president and head of US Gastroenterology Business Unit at Takeda, said in the press release. “With [budesonide], patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during 2 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

The most common adverse reactions with budesonide according to the press release included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%) in study 1, with the safety data being generally similar in study 2, according to the press release.


FDA approves Takeda’s Eohilia (budesonide oral suspension) the first and only oral treatment in the US for Eosinophilic Esophagitis (EoE). News release. Takeda. February 12, 2024. Accessed February 12, 2024. https://www.takeda.com/newsroom/newsreleases/2024/fda-approves-eohilia/

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