Eohilia Gets FDA Approval for Swallowing Disorder Eosinophilic Esophagitis
[ad_1]
The U.S. Food and Drug Administration (FDA) has approved the first oral treatment for eosinophilic esophagitis, a rare condition caused by allergic inflammation in the esophagus that can make it hard to swallow food.
“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,” said Brandon Monk, the senior vice president and head of the U.S. Gastroenterology Business Unit at Takeda, in the 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,” Monk said.
In both studies, patients with EoE were randomly selected to take either Eohilia or a placebo liquid twice daily for 12 weeks. Scientists measured the effectiveness of treatment by how often it reduced levels of immune cells known as eosinophils enough to effectively put EoE in remission.
EoE Symptom Remission With Eohilia
In one study, 53 percent of patients on Eohilia achieved remission compared with 1 percent on placebo. In the other study, 38 percent of Eohilia patients achieved remission compared with 2.4 percent in the placebo group.
Patients taking Eohilia in both studies reported significantly less difficulty swallowing after 12 weeks of treatment. And they were also more likely to report that swallowing challenges completely went away.
The most common side effects with Eohilia were respiratory tract infections, yeast infections in the gastrointestinal tract, and headaches.
What Is Eosinophilic Esophagitis (EoE)?
EoE is a chronic inflammatory disease of the esophagus, the tube that transports food from the mouth to the stomach. While the exact cause is unknown, it’s thought to be triggered by allergic reactions to certain foods, according to Takeda.
Patients with this condition are sometimes put on what’s known as an elimination diet, in which they stop eating a wide variety of foods that may cause allergic reactions, then reintroduce foods one at a time to pinpoint what triggers their symptoms. If a culprit is identified, then patients are advised to limit that food in their diet.
Other Medications for Eosinophilic Esophagitis
Corticosteroids in other forms like creams or pills may also be used to treat EoE. The injected biologic medicine Dupixent (dupilumab) is used for some people who don’t respond to alternatives.
For years, doctors have also prescribed inhaled or hand-mixed versions of oral corticosteroids for EoE, even though these options aren’t specifically FDA approved for this condition, says Evan Dellon, MD, MPH, a professor and the director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina in Chapel Hill. But this was an imperfect solution.
“As a provider, I was never sure how much medication my patient was getting or how effectively it was being delivered to the esophagus,” Dr. Dellon says. An advantage of Eohilia is that patients will get a premixed dose that’s designed specifically to be swallowed, travel to the esophagus, and treat the symptoms of EoE.
When swallowed, steroids like budesonide (the active ingredient in Eohilia) and fluticasone (the active ingredient in the now-discontinued asthma drug Flovent) work by coating the lining of the esophagus to treat the inflammation on contact — similar to the way a steroid cream on the skin relieves a rash or eczema.
“Swallowed topical steroids like budesonide and fluticasone are some of the most frequently utilized medications to treat EoE and are effective in a large proportion of patients,” says Erin Syverson, MD, the associate director of the Eosinophilic Gastrointestinal Disease Program at Boston Children’s Hospital.
Up until now, however, patients have either needed to mix steroids into liquid doses on their own or have the medicine custom blended by a compounding pharmacy, an option that typically isn’t covered by insurance, Dr. Syverson says.
“Having a commercially available product like Eohilia will potentially help to overcome some of the barriers to budesonide’s use in EoE, which would standardize medication preparation and dosing, while also potentially making it easier for patients to be compliant with taking medication, since it comes in a ready-to-use preparation,” Syverson says.
[ad_2]
