Takeda’s Budesonide Oral Suspension Receives FDA Approval for EoE

FDA has approved budesonide oral suspension to treat patients 11 years of age and older with eosinophilic esophagitis (EoE). The oral therapy, to be sold as Eohilia, will be available by the end of February, according to sponsor Takeda.

The treatment, to be distributed in 2 mg/10 mL single-dose stick packs, is a corticosteroid that is designed to flow freely when shaken and revert to a viscous state when swallowed, according to a statement from Takeda. FDA has approved the budesonide oral suspension therapy to be taken twice a day for 12 weeks, based on studies involving patients aged 11 to 56 who have EoE, a chronic inflammation of the esophagus that can cause choking and making swallowing painful.

“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,” Brandon Monk, senior vice president and head, US Gastroenterology Business Unit, Takeda, said in the statement.

EoE is an inflammatory disease localized in the esophagus. It is believed to be triggered by certain foods or environmental allergens, although the exact cause is unknown. Symptoms can range widely and include difficulty swallowing, vomiting, and pain. It is difficult to diagnose, and left untreated, can cause the esophagus to narrow, allowing food to become stuck in the esophagus. The condition is the leading cause of emergency department visits for food impaction.

Until now, “Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With [budesonide oral suspension], it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine, said in the statement.

He added that the treatment offers “flexibility” as an oral medication.

Approval is based on on efficacy and safety data from 2 multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies; the first involved patients aged 11 to 56 and the second involved patients aged 11 to 42. Both called for patients to receive either a 2 mg dose of the study therapy or placebo twice daily.

Efficacy end points included measures of remission based on peak eosinophil count of 6 or less per high-powered field across all available esophageal levels, and the change from baseline in patient-reported outcomes, based on the Dysphagia Symptom Questionnaire (DSQ) combined score after 12 weeks of treatment. The DSQ measures how often a patient with EoE has difficulty swallowing and the ways they adapt to this condition.

In the measure based on eosinophil count, 53.1% patients in the first study taking the study drug achieved remission vs 1% taking placebo; in the second study, the difference was 38% among those taking the study drug vs 2.4% taking placebo.

Differences in scores from baseline in combined DSQ were: in the first study, a reduction of 10.2 vs 6.5, favoring budesonide oral suspension; in the second study, a reduction of 14.5 vs 5.9, again favoring budesonide oral suspension over placebo. In the final 14 days of each study, more patients taking the study therapy experienced no dysphagia or experienced dysphagia that “got better or cleared up on its own” compared with placebo, according to the DSQ.

Safety results show the most common adverse events among those taking the study therapy are respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%) and erosive esophagitis (2%). The safety results were generally similar across both studies.