Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE) in individuals aged 11 years and older. This approval makes EOHILIA the first and only FDA-approved oral therapy for EoE and is expected to be available by the end of February in 2 mg/10 mL single-dose stick packs.

EoE is a chronic condition characterized by esophageal inflammation and symptoms such as choking, and difficulty or pain while swallowing. The approval of EOHILIA is based on efficacy and safety data from two randomized, double-blind, placebo-controlled 12-week studies. In this research, EOHILIA demonstrated the ability to alleviate esophageal inflammation and reduce dysphagia symptoms.

EOHILIA’s novel formulation allows for consistent dose delivery with thixotropic properties, which means it flows more easily when shaken and thickens upon swallowing. Dr. Ikuo Hirano, a gastroenterology professor at Northwestern University, emphasized the significance of having an FDA-approved, specifically formulated treatment that can offer a consistent dose delivery for managing EoE.

The FDA approval is supported by results showing that a significantly higher percentage of patients receiving EOHILIA achieved histologic remission compared to those on placebo in both studies. Additionally, improvements were seen in the Dysphagia Symptom Questionnaire (DSQ) scores, which assess the frequency and behavioral adaptations related to swallowing difficulties in EoE patients.

While EOHILIA is indicated for 12 weeks of treatment, it has not proven safe and effective beyond this duration. Common adverse reactions (≥2% of patients and greater than placebo) included respiratory tract infection, gastrointestinal mucosal candidiasis, headache, and other conditions. These reactions underscore the importance of monitoring patient outcomes with the new treatment.

This approval of EOHILIA presents a promising option for clinicians and patients dealing with the unmet needs of EoE and enhances Takeda’s ongoing commitment to addressing various disease areas through innovative therapeutic solutions.

Source link: http://www.businesswire.com/news/home/20240209115096/en/FDA-Approves-Takeda%E2%80%99s-EOHILIA-budesonide-oral-suspension-the-First-and-Only-Oral-Treatment-in-the-U.S.-for-Eosinophilic-Esophagitis-EoE

author avatar
Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.