The FDA approval was based on efficacy and safety findings from two multicentre, randomised, double-blind, parallel-group, placebo-controlled 12-week studies
Takeda secures FDA approval for Eohilia in eosinophilic esophagitis. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has received approval from the US Food and Drug Administration (FDA) for Eohilia (budesonide oral suspension) as oral treatment in people 11 years and older with eosinophilic esophagitis (EoE).
Eohilia is a corticosteroid indicated for 12 weeks of therapy. Its formulation of budesonide confers thixotropic properties.
The drug will be available in 2mg/10mL single-dose stick packs by the end of this month.
The FDA approval was based on efficacy and safety findings from two multicentre, randomised, double-blind, parallel-group, placebo-controlled 12-week studies.
Takeda senior vice president and US gastroenterology business unit head Brandon Monk said: “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.
“With Eohilia, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce oesophageal inflammation and improve the ability to swallow.”
Study 1 assessed Eohilia in EoE patients aged 11 to 56 whereas Study 2 evaluated patients aged 11 to 42.
Both trials administered at least one dose of either Eohilia 2mg twice daily or placebo orally twice daily.
Efficacy endpoints consisted of histologic remission and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ) combined score post 12 weeks of therapy.
In Study 1, substantially more patients receiving Eohilia, at 53%, achieved histologic remission against the placebo (1%). In Study 2, 38% of the therapy patients achieved histologic remission in comparison to 2.4% of those in the placebo arm.
In Study 1, the Eohilia vs. placebo groups’ absolute change from baseline in the DSQ combined score was -10.2 vs. -6.5, and in Study 2, it was -14.5 vs. -5.9.
In comparison to placebo, more patients taking the drug had dysphagia that “got better or cleared up on its own” or no dysphagia at all during the final two weeks of each trial, according to the DSQ.
However, the therapy is not safe and effective for the treatment of eosinophilic esophagitis for longer than 12 weeks, the Japanese pharmaceutical company said.