FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
Takeda has announced that the U.S. Food and Drug Administration has approved Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.
Eohilia is a corticosteroid indicated for 12 weeks of treatment in patients and was developed specifically for EoE. Eohilia’s novel formulation of budesonide confers thixotropic properties, thus flowing more freely when shaken and returning to a more viscous state when swallowed.
EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus. Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens. The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.
Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).
Eohilia has not been shown to be safe and effective for the treatment of EoE for Longer than 12 weeks.
Warnings and Precautions:
• Hypercorticism and Adrenal Axis Suppression
• Immunosuppression and Increased Risk of Infection
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