Monday, the FDA approved Takeda Pharmaceutical Co Ltd’s TAK Eohilia (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE), a chronic, immune-mediated, inflammatory disease localized in the esophagus, a tube through which the food reaches the stomach for further digestion.
It will be available in convenient 2 mg/10 mL single-dose stick packs by the end of February.
Eohilia is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE.
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The FDA approval is based on efficacy and safety data from two studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE.
Significantly more patients receiving Eohilia achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%).
In Study 2, 38% of Eohilia patients achieved histologic remission vs. 2.4% of those in the placebo group.
Absolute change from baseline in the Dysphagia Symptom Questionnaire (DSQ) combined score in the Eohilia vs. placebo groups in Study 1 was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9 (2.1).
The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported directly by patients.
During the last two weeks of each study, more patients receiving Eohilia experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo.
Eohilia has not been shown to be safe and effective for treating EoE for longer than 12 weeks.
Price Action: TAK shares are up 0.25% at $14.27 on the last check Monday.
