FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis Treatment

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Zara Nwosu
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FDA Approves Budesonide Oral Suspension for Eosinophilic Esophagitis Treatment

A New Hope for Eosinophilic Esophagitis Patients

The U.S. Food and Drug Administration (FDA) has recently approved budesonide oral suspension, commercially known as Eohilia, for the treatment of eosinophilic esophagitis (EoE) in adults and children aged 11 and older. EoE is a chronic inflammatory disease of the esophagus, which can cause symptoms such as difficulty swallowing, vomiting, and chest pain. The approval of Eohilia brings new hope to those suffering from this condition, as it offers a significant improvement in managing esophageal inflammation and EoE dysphagia symptoms.

Understanding Eohilia: FDA’s Second Approved Drug for EoE

Eohilia is a corticosteroid delivered as a 2-mg dose twice daily over a 12-week course. It is specifically formulated to flow freely when shaken and revert to a viscous state when swallowed. This ensures consistent dose delivery to the esophagus. Following injectable dupilumab (Dupixent), Eohilia is the second drug approved by the FDA for the treatment of EoE, and importantly, it is the first oral therapy for this patient demographic.

Clinical Trials Support Eohilia’s Efficacy

The FDA's approval of Eohilia was based on positive results from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. These studies demonstrated significant histologic remission in EoE patients taking Eohilia, thus highlighting its effectiveness in reducing eosinophilic inflammation in the esophagus. However, the safety and efficacy of Eohilia for EoE have not been established beyond 12 weeks of use.

Adverse Reactions and Precautions

While Eohilia offers significant benefits for patients with EoE, it also comes with some potential adverse reactions. The most common of these include respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis. It's important for patients and healthcare providers to be aware of these potential side effects.

Eohilia is contraindicated in individuals with hypersensitivity to corticosteroids and is not recommended for use during pregnancy or in people with severe liver impairment. It is also expected to be available by the end of February in 2 mg/10 mL single-dose stick packs, making it a convenient option for patients and care providers.

Conclusion

The approval of Eohilia by the FDA marks a significant milestone in the treatment of EoE. As the first and only FDA-approved oral therapy for this condition, it has the potential to drastically improve the quality of life for many patients. However, as with any medication, it is important for patients to discuss potential risks and benefits with their healthcare provider before starting treatment.