The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO: 4502)’s Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). This marks Eohilia as the first and currently only oral therapy available for EoE patients aged 11 and older. Previously, Novartis (NYSE: NVS)’s Dupixent (dupilumab) was approved for EoE treatment in children aged 1 to 11 weighing at least 15 kg, as well as in patients aged 12 and above with a minimum weight of 40 kg.
The FDA’s decision is supported by data from two multi-center, randomized, double-blind, placebo-controlled Phase III studies, where patients received Eohilia 2 mg or a placebo twice daily. In Study 1, Eohilia demonstrated significantly higher rates of histological remission compared to placebo, with 53.1% of patients achieving remission versus just 1% in the placebo group. Study 2 also showed promising results, with 38% of Eohilia patients reaching histological remission, compared to 2.4% for placebo. Additionally, the comprehensive Dysphagia Symptom Questionnaire (DSQ) scores indicated significant improvements for Eohilia patients relative to baseline. However, it remains unconfirmed whether Eohilia is safe and effective for treating EoE beyond a 12-week period.- Flcube.com
