Takeda announced this week that it received FDA approval for its Eohilia (budesonide oral suspension) therapy.
This makes Eohilia the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE). Takeda plans to offer it in 2 mg/10 mL convenient, single-dose stick packs by the end of February.
Eohilia, a corticosteroid, is indicated for 12 weeks of treatment in patients 11 years and older with EoE. Developed specifically for EoE, the novel formulation of budesonide confers thixotropic properties, according to a news release. This allows for more free flow when shaken, returning to a more viscous state when swallowed.
Takeda picked up approval on the back of efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies.
“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, SVP and head, U.S. Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”
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