OSAKA, Japan & CAMBRIDGE, Mass. - Takeda Pharmaceutical Company (NYSE:TAK) Limited (TSE:4502/NYSE:TAK) recently announced the FDA approval of EOHILIA, a new treatment for eosinophilic esophagitis (EoE) in individuals aged 11 and older. This marks the first FDA-approved oral therapy for this condition and is expected to be available by the end of February.
EoE is a chronic immune-mediated disease that causes inflammation in the esophagus, leading to symptoms like choking and painful swallowing. EOHILIA, a budesonide oral suspension, is designed for a 12-week treatment course. Its unique formulation allows it to change viscosity, making it easier to swallow.
The FDA's decision was based on two placebo-controlled studies, which showed that EOHILIA significantly improved histologic remission and swallowing difficulties compared to placebo. The most common side effects were respiratory tract infection, throat irritation, and gastrointestinal issues.
While EOHILIA has been approved for a 12-week treatment duration, its safety and efficacy beyond this period have not been established. Takeda is evaluating the financial implications of the approval for the fiscal year ending March 31, 2024, but does not expect a material impact.
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