Skip to main content

FDA Approves Eohilia for Eosinophilic Esophagitis

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 16, 2024.

By Lori Solomon HealthDay Reporter

FRIDAY, Feb. 16, 2024 -- The U.S. Food and Drug Administration has approved Eohilia (budesonide oral suspension) as the first and only oral treatment for eosinophilic esophagitis (EoE).

The oral corticosteroid therapy is approved for individuals aged 11 years and older and will be available in 2-mg/10-mL single-dose stick packs by the end of February. The approval calls for twice-daily use for 12 weeks of treatment.

The approval is based on two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies in patients (ages 11 to 56 and 11 to 42 years, respectively). The two studies revealed that significantly more patients receiving Eohilia achieved histologic remission versus those receiving placebo (study 1: 53.1 versus 1 percent; study 2: 38 versus 2.4 percent). From baseline, the absolute change in the Dysphagia Symptom Questionnaire combined score was −10.2 with Eohilia versus −6.5 with placebo in study 1 and −14.5 and −5.9, respectively, in study 2. Compared with those taking placebo, more patients receiving Eohilia experienced no dysphagia or only experienced dysphagia that "got better or cleared up on its own" during the last two weeks of each study.

"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 of the U.S. Gastroenterology Business Unit at Takeda, said in a statement. "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 esophageal inflammation and improve the ability to swallow."

The approval of Eohilia was granted to Takeda.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2024 HealthDay. All rights reserved.

Posted February 2024

Read this next

FDA Approves Dupilumab for Children With Eosinophilic Esophagitis

MONDAY, Jan. 29, 2024 -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of pediatric patients (aged 1 to 11 years) with eosinophilic...

American College of Chest Physicians, Oct. 8-11

The annual meeting of the American College of Chest Physicians was held this year from Oct. 8 to 11 in Honolulu and attracted participants from around the world, including...

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.