FDA Approves the First Oral Treatment for Eosinophilic Esophagitis

Fact checked by Nick Blackmer

Key Takeaways

• The FDA approved Takeda’s Eohilia, the first and only oral medication for the treatment of EoE.

• EoE is an inflammatory condition in the esophagus. When inflammation worsens, it can cause trouble and pain while swallowing or eating.

• Before Eohilia’s approval, Dupixent was the only other FDA-approved treatment option for people with EoE.

Everyday eating and swallowing can be difficult and painful for patients with eosinophilic esophagitis (EoE). As a result of the body’s immune response to ingested food or allergens in the air, EoE patients may experience extreme swelling and inflammation in the esophagus. Managing the condition is hard as it is, and was exacerbated by limited treatment options.

Recently, the Food and Drug Administration (FDA) approved an drug called Eohilia, a budesonide oral suspension treatment for EoE. This approval was a result of a lengthy process spanning several years; the FDA initially rejected the drug in 2021.

The EoE community “actually helped us bring this drug to market,” Vijay Yajnik, MD, Takeda’s U.S. medical director for gastroenterology, told Verywell.

As a result of the community’s push, Takeda pursued conversations with the FDA on a path forward, ultimately resubmitting the drug’s application with additional data regarding its benefits in October of 2023. Now, Eohilia is the first and only oral therapy for people with EoE.

How Does It Work?

The twice-daily treatment is currently approved for people 11 and older for up to 12 weeks.

The treatment is packaged in single-dose packets that need to be shaken and taken 30 minutes before food consumption.

“The idea is that the budesonide medication hangs in the esophagus,” Yajnik said. The treatment is intended to directly address the site of esophageal inflammation and EoE symptoms.

How Well Does It Work?

In phase 3 clinical trials, patients between 11 and 55 years of age who received two milligrams twice daily achieved 53% histologic remission after 12 weeks of treatment, compared to 1% taking the placebo. Histologic remission is an important sign in people with EoE, as it indicates that the inflammation in the esophagus has resolved and the tissue has healed.

With any EoE therapy, the goal is to get patients in remission and then reduce the amount of therapy a patient is taking, Brooks D. Cash, MD, a gastroenterologist at UT Health Houston and Memorial Hermann, told Verywell.

Eohilia is an oral corticosteroid—corticosteroids are generally a safe medication prescribed to treat inflammation.

“There is recent data demonstrating that long-term budesonide appears quite safe, but we try not to continue steroids in perpetuity,” Cash said. That’s because long-term corticosteroid use can have potential side effects like bone loss and skin thinning.

“Eohilia is an effective first-line therapy, but we may have to escalate therapy to immune modulators if patients cannot maintain remission off of budesonide,” Cash added.

Why Another Approved Medication Matters

An EoE patient’s white blood cells build in the esophagus, causing damage and inflammation. When inflammation worsens, EoE can make swallowing and eating extremely painful and challenging.

Research shows that children with EoE are more likely to have feeding disorders and recurring vomiting due to esophageal inflammation, underscoring that EoE can have serious health implications if left untreated or unmanaged.

Before Eohilia, the only other FDA-approved treatment option was Dupixent, an injectable monoclonal antibody used for multiple allergy-related conditions.

In the absence of other FDA-approved options, some patients resorted to other means.

“Prior to this approval, patients had to go to a compounding pharmacy or make up their own DIY formulation of budesonide, which was inconvenient, and in some cases, prohibitively expensive,” Cash said. “This also limited their compliance with a potentially effective therapy, potentially leading to more long-term complications.”

Unlike Dupixent, which blocks the sources of inflammation, Eohilia is designed to treat EoE directly at the site: the esophagus itself. “It works quickly and is relatively convenient for patients to administer,” Cash said.

In patients who have not responded well to Eohilia, elimination diet therapy, or PPI therapy—or in patients who have not maintained remission through those treatments—Dupixent is still a good option, Cash added.

What This Means For You

An oral medication to help treat eosinophilic esophagitis is here. But it’s not intended for long-term use. Dupixent, an injectable approved to treat EoE since 2022, may still be the best option for some.

Read the original article on Verywell Health.