The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company Limited for EOHILIA® (budesonide oral suspension), a novel oral therapy for the treatment of Eosinophilic Oesophagitis (EoE), a rare chronic inflammatory disease of the oesophagus. 

EOHILIA® is another medication besides Dupixent® (dupilumab) that was approved in the US and EU for EoE, which affects approximately 150,000 people in the U.S.

Key takeaways:

• Eosinophilic oesophagitis (EoE) is a chronic condition that causes inflammation of the oesophagus and, if untreated, can lead to oesophagus strictures, dysphagia (difficulty swallowing) and food impaction.
• EOHILIA® is a corticosteroid with thixotropic properties. This means it flows more freely when shaken and becomes more viscous when swallowed, allowing it to coat the oesophagus and reduce inflammation and dysphagia.
• Studies have shown that EOHILIA® is effective in patients aged 11 and above. It significantly improved histologic remission (reduction of eosinophils in the oesophagus) and patient-reported dysphagia symptoms compared to placebo.

What is Eosinophilic Oesophagitis

EoE is characterised by elevated levels of eosinophils, a type of white blood cell, in the oesophagus (food pipe), causing inflammation and damage to the tissue. Patients with EoE may experience difficulty swallowing, food impaction, chest pain, vomiting, and poor growth. 

Learn more about subtle changes in your eating comfort, which can be a symptom of the disease.

Treatment Options For EoE

There are limited treatment options for treating EoE, including dietary elimination of potential allergens, topical corticosteroids, and oesophageal dilation. However, these treatments have limitations, such as difficulty in adherence, side effects, recurrence of symptoms, and risk of complications. Therefore, there is an unmet need for more effective and safe therapies for EoE.

The Study Results

The FDA has approved EOHILIA® 2 mg, administered orally twice daily, for the treatment of EoE based on results from two key studies involving patients aged 11 to 56 and 11 to 42. 

These multicenter, randomised, double-blind, placebo-controlled trials assessed the drug’s efficacy and safety over a 12-week period. The primary measures of efficacy were histologic remission (defined as a peak eosinophil count of ≤6 per high-powered field) and the change from baseline in the Dysphagia Symptom Questionnaire (DSQ) combined score, which reflects the frequency and severity of swallowing difficulties.

EOHILIA® led to more patients achieving histologic remission and substantial improvement in DSQ scores compared to placebo, indicating reduced swallowing difficulties.

The drug’s safety profile was consistent across both studies. The most common adverse reactions were respiratory tract infections, gastrointestinal mucosal candidiasis, and headaches.

How EOHILIA Works

EOHILIA® is administered as an oral suspension twice daily using an oral syringe. The recommended daily dosage is 2 mg for patients aged 11 years and older and 1 mg for those aged 3 to 10. 

EOHILIA®’s unique formulation of budesonide has thixotropic properties, allowing it to flow more easily when shaken and return to a more dense state when swallowed, developed explicitly for treating EoE.

EOHILIA® is expected to be available in the U.S. in the first quarter of 2024.

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Updated: 21/03/2024 [Quote removed]