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# Takeda’s Eohilia OK’d for Eosinophilic Esophagitis
- URL: https://www.fdaweb.com/takedas-eohilia-okd-for-eosinophilic-esophagitis/
- Published: 2024-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:22:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156341

FDA has approved a Takeda NDA for Eohilia (budesonide oral suspension), indicated for treating eosinophilic esophagitis (EoE) in patients aged 11 years and older. The corticosteroid was approved based on efficacy and safety data from two multicenter placebo-controlled 12-week studies (Study 1 and Study 2) in patients with EoE.

“Significantly more patients receiving Eohilia achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%),” the company says. “In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group.”

The chronic, immune-mediated, inflammatory disease is localized in the esophagus, according to the company. “Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens,” it says. “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.”