TOKYO (dpa-AFX) - Japan's Takeda Pharmaceutical Co. Ltd. (TAK) announced Monday that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE)1 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 11 years and older with EoE. Developed specifically for EoE, EOHILIA's novel formulation of budesonide confers thixotropic properties - flowing more freely when shaken and returning to a more viscous state when swallowed.
The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies in patients of ages 11 to 56 and 11 to 42, respectively, with EoE.
Takeda is assessing the financial impacts of the approval, including a reversal of impairment loss for intangible assets, on the fiscal year ending on March 31, 2024 (FY23), but does not anticipate the impact to be material.
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