FDA OKs First Oral Agent for Eosinophilic Esophagitis

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

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

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

"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 company said in a news release.

Source: MEDspace