Home Medizin FDA genehmigt erstes orales Mittel gegen eosinophile Ösophagitis

FDA genehmigt erstes orales Mittel gegen eosinophile Ösophagitis

von NFI Redaktion

The Food and Drug Administration (FDA) has approved the oral suspension of budesonide (Eohilia, Takeda) as the first oral treatment for eosinophilic esophagitis (EoE).

Budesonide oral suspension is a corticosteroid indicated for the 12-week treatment of EoE in adults and children aged 11 and older. It will be available in single-dose stick packs containing 2 mg/10 ml starting at the end of February.

„Eohilia’s novel budesonide formulation has been specifically developed for EoE, imparting thixotropic properties – it flows more freely upon shaking and returns to a more viscous state upon swallowing,“ the company stated in a press release. „Various formulations of corticosteroids have been used in the past to treat EoE, but off-label and with multiple administration options. With Eohilia, it is gratifying to now have an FDA-approved treatment specifically designed for consistent dosing with proven effectiveness in combating esophagus inflammation and EoE dysphagia symptoms,“ said Dr. Ikuo Hirano, Professor of Medicine and Director of the Esophageal Center at the Feinberg School of Medicine, Northwestern University in Chicago, in the press release.

Supportive data
The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, placebo-controlled parallel group studies over 12 weeks.

In study 1, a significantly higher percentage of patients receiving active treatment achieved histological remission (53.1% vs. 1% with placebo). The same was true for study 2: 38% of patients receiving active treatment achieved histological remission, compared to 2.4% of patients receiving placebo.

The absolute change from baseline in the combined score of the patient-reported Dysphagia Symptom Questionnaire was -10.2 with budesonide vs. -6.5 with placebo in study 1 and -14.5 vs. -5.9 in study 2.

During the last two weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only dysphagia that „improved or resolved on its own“ compared to those receiving placebo, according to the company.

The most common adverse effects observed in clinical studies of budesonide oral suspension for EoE included respiratory tract infections (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). Complete prescribing information is available online.

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