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# Takeda NDA for Eosinophilic Esophagitis Drug Accepted
- URL: https://www.fdaweb.com/takeda-nda-for-eosinophilic-esophagitis-drug-accepted/
- Published: 2020-12-17T12:00:00.000Z
- Updated: 2026-09-14T16:40:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148334

FDA has accepted for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus. The NDA is based on data from the pivotal Phase 3 trials ORBIT1 and ORBIT2, which investigated the safety and efficacy of TAK-721 in adolescent and adult patients (11 to 55 years of age) with EoE, the company says. Budesonide is described as a novel mucoadherent topically active oral viscous formulation.

Takeda says the exact cause of EoE is unknown, but it is “believed to be triggered by a variety of stimuli including certain foods and environmental allergens. 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 heartburn.”