FDA Approves Takeda’s Eohilia for Eosinophilic Esophagitis
February 12, 2024
Rare Daily Staff
The U.S. Food and Drug Administration has approved Eohilia, the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis.
Eosinophilic esophagitis (EoE) is a rare, chronic, immune-mediated, inflammatory disease localized in the esophagus. Although the exact cause is unknown, 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 pain. Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus, and EoE is the leading cause of emergency room visits for food impaction.
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 is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. Significantly more patients receiving Eohilia achieved histologic remission compared to placebo in Study 1 (53.1percent vs. 1 percent). In Study 2, 38 percent of Eohilia patients achieved histologic remission vs. 2.4 percent of those in the placebo group.
“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda. “With Eohilia, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown in two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”
Takeda said Eohilia will be available by the end of February.
Photo: Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda
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