FDA Approves Budesonide Oral Suspension for EoE

The U.S. Food and Drug Administration (FDA) on February 12 approved budesonide oral suspension (Eohilia) for treatment of eosinophilic esophagitis (EoE).

The first and only FDA-approved oral therapy is indicated for 12 weeks of treatment among people 11 years and older with EoE. This novel formulation of budesonide is formulated to flow freely when shaken but convert to a more viscous state when swallowed.

In two multicenter, randomized, double-blind, placebo-controlled 12-week studies were in patients with EoE, significantly more patients receiving budesonide oral suspension achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%) and Study 2 (38.0% vs. 2.4% of those in the placebo group.

The most common adverse reactions included seen in both trials included respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation,  adrenal suppression, and erosive esophagitis (2%).

Eohilia is a product of Takeda.