Takeda has received US Food and Drug Administration (FDA) approval for EOHILIA (budesonide oral suspension), an oral treatment for eosinophilic esophagitis (EoE), an allergic condition that causes inflammation of the oesophagus.
The corticosteroid is indicated for usage in individuals aged 11 years and above for 12 weeks.
It will be offered as 2mg/10ml single-dose stick packs by the end of February 2024.
EOHILIA’s unique formulation of budesonide has thixotropic properties, allowing it to flow more easily when shaken and become viscous upon swallowing.
The latest approval for the 2mg twice-a-day regimen of EOHILIA is based on findings from two multicentre, randomised, placebo-controlled, double-blind clinical trials, demonstrating its efficacy and safety over 12 weeks.
Subjects aged 11 to 56 and 11 to 42 years were administered at least one dose of EOHILIA or a placebo orally twice a day.
The trial’s efficacy endpoints were histologic remission and change from baseline in the subject-reported dysphagia symptom questionnaire (DSQ) combined score after 12 weeks.
Data showed improvements in subjects treated with EOHILIA versus those in the placebo arm.
In study one, 53.1% of EOHILIA patients achieved histologic remission versus 1% in the placebo group.
Study two reported a 38% remission rate for EOHILIA patients compared to 2.4% for placebo arm patients.
The DSQ combined score showed a greater reduction from baseline in the EOHILIA groups of both studies.
Takeda US gastroenterology business unit senior vice-president and head Brandon Monk stated: “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 shown during two 12-week clinical studies to reduce oesophageal inflammation and improve the ability to swallow.”
This month, Takeda signed a global licence and partnership agreement with Protagonist Therapeutics to develop and market rusfertide.
