Takeda's EOHILIA (Budesonide Oral Suspension) Receives FDA Approval as First Oral Therapy for Eosinophilic Esophagitis

Feb 13, 2024 07:34 CST Updated 07:34

Takeda

Biopharmaceutical Manufacturer

▎Edited by the WuXi AppTec content team

Today, Takeda announced that the U.S. FDA has approved Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE) in patients aged 11 years and older. The press release noted,This is the first FDA-approved oral therapy for the treatment of EoE, with the potential to address a significant unmet need for patients.

The FDA approval was based on two 12-week randomized, double-blind, placebo-controlled clinical trials. In these two trials, participants received either Eohilia or a placebo twice daily. The trial results showed,The proportion of patients in the Eohilia group achieving histologic remission was 53.1% in Study 1, significantly higher than the placebo group (1%). In Study 2, this figure was 38% for the Eohilia group and 2.4% for the placebo group.During the last two weeks of the clinical trial, more patients in the Eohilia group did not experience dysphagia, or their symptoms of dysphagia were alleviated or spontaneously resolved.

The most common adverse reactions in Study 1 included: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). The safety profile of Eohilia in Study 2 was generally similar to that in Study 1.

EohiliaIt is a novel oral viscous formulation of budesonide that can locally adhere to the mucosa, thereby exerting activity in the esophagus. It is a formulation specifically designed for EoE.Budesonide is a glucocorticoid, and its other formulations have been used to treat inflammatory diseases such as asthma, chronic obstructive pulmonary disease, allergic rhinitis, and nasal polyps.

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References:

[1] FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE). Retrieved February 12, 2024, from https://www.businesswire.com/news/home/20240209115096/en

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