FDA Approves EOHILIA™ to Treat EoE in People Ages 11 and Older

FDA Approves EOHILIA™ to Treat EoE in People Ages 11 and Older

The budesonide oral suspension is the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE)

February 19, 2024:  APFED (The American Partnership for Eosinophilic Disorders) is excited to share that the U.S. Food and Drug Administration (FDA) has approved Eohilia™ oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).

Eohilia, a treatment developed by Takeda, is an oral corticosteroid now indicated to treat EoE for 12 weeks.

EoE is a chronic inflammatory condition characterized by the presence of eosinophils, a type of white blood cell in the esophagus.  Eosinophils cause inflammation in the esophagus and damage to the tissue, leading to symptoms of difficulty swallowing, food getting stuck in the esophagus, pain, vomiting, and malnutrition.  Treatments to date have included dietary eliminations, proton pump inhibitors, dupilumab (a biologic), and the “off-label” use of swallowed corticosteroids to treat inflammation in the esophagus caused by EoE.

“Off-label” use of a medication for EoE means the therapy is indicated to treat other conditions, but not specifically EoE. Patients prescribed this therapy have long-reported challenges with having to mix off-label prescription of budesonide into a slurry with various carrier ingredients, such as artificial sweetener or applesauce, and reported challenges with dosing, consistency, and insurance coverage.

“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,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda, in a company press release announcing Eohilia’s approval.

To support patients during their treatment journey, Takeda offers the Eohilia Patient Support and Copay Program. Commercially-insured patients may be eligible to pay as little as $0 for Eohilia. Patients can sign up now at https://www.eohilia.com/sign-up to get updates on the program and learn when Eohilia will be available.

APFED congratulates Takeda for their commitment and perseverance in developing Eohilia™, as well as those who have advocated for the approval of this therapy, and the patients who participated in research and clinical trials.

“We are thrilled that people living with EoE have a new indicated treatment available,” said APFED’s President Dr. Wendy Book. “Thanks to the generosity of APFED donors, we awarded our first HOPE on the Horizon research grant in 2008 to Dr. Seema Aceves, a clinician and researcher from San Diego, CA, whose research project helped pave the way for this therapy to develop.”

Dr. Prad Tummala, Chairman of APFED’s Board of Directors, stated, “APFED is committed to fostering innovative research of eosinophilic disorders. The FDA’s approval of Eohilia™ is a significant milestone in the management of EoE and brings hope to those affected by this condition. It also underscores the importance of investing in research through a carefully vetted process. We are incredibly appreciative of donations to APFED that make advances like this possible.”

Ryan Piansky, a young adult who was diagnosed with EoE in early childhood, shared, “Patients and families have waited a long time for an FDA approved oral therapy for EoE. As someone who lives with EoE and as a long-time supporter of APFED’s HOPE on the Horizon Research Program, I am so excited that a new treatment option is available that was made possible by the involvement of APFED’s community.”

To learn more about APFED’s HOPE on the Horizon Research Program and to donate to research efforts, please visit apfed.org.