The U.S. Food and Drug Administration (FDA) has approved a medication for an esophageal disease that makes it difficult to swallow food.
The FDA approved Eohilia for use among individuals aged 11 years and older who have eosinophilic esophagitis (EoE), Japan-based Takeda Pharmaceutical said in a Feb. 12 press release.
EoE is a chronic immune system disease in which a type of white blood cells builds up in the esophagus tube lining connecting the stomach to the mouth. This buildup can injure or inflame the esophagus, making it difficult to swallow food. In some cases, the food can get stuck in the tube when trying to swallow.
Takeda said that Eohilia is the “first and only FDA-approved oral therapy” available for EoE for individuals aged above 11 years. The company expects the medication to be made available in 2-mg doses at the end of this month.
The FDA approval was based on two trials conducted by Takeda among patients with EoE. In both studies, subjects received at least one dose of either Eohilia 2 mg twice daily or placebo orally twice daily.
In the first study, 53.1 percent of participants taking Eohilia achieved “histologic remission” compared to only 1 percent in the placebo group. In the second study, 38 percent of the Eohilia group achieved histologic remission against 2.4 percent in the placebo participants.
“During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia (difficulty swallowing) or only experienced dysphagia that ‘got better or cleared up on its own’ as compared to placebo.”
Takeda pointed out that Eohilia “has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.”
The company had earlier submitted documents to get Eohilia approved by the FDA. The agency rejected the submission in 2021. At the time, Takeda decided to discontinue the drug development.
However, in October 2023, R&D chief Andy Plump said they refiled for approving Eohilia a month ago as a 12-week treatment.
“Strong data and remaining unmet need in the U.S. spurred significant grassroots support” for the drug in EoE communities, he said, according to Fierce Pharma.
In the updated application, the company focused on the drug’s 12-week data, shifting the spotlight away from the findings of a one-year maintenance study, per the outlet.
Side Effects
According to the FDA, Eohilia comes with “serious side effects” including having too much “corticosteroid medicine in your blood” that can result in acne, rounding of the face, thicker body hair, pink or purple stretch marks on some areas of the skin, and swelling of the ankle.Long-term use of Eohilia can result in adrenal suppression, where the glands do not make enough steroid hormones. This can result in tiredness, weakness, low blood pressure, and nausea.
Patients taking the medication can experience “decreased ability of your body to fight infections (immunosuppression) and increased risk of infection.”
Those who have latent/inactive tuberculosis may see the condition become active again when taking the drug, the FDA stated.
People who have not had chickenpox or measles but take Eohilia “should avoid contact with people who have these diseases.” Those who are carriers of the Hepatitis B virus may see the microbe becoming active again after taking the drug.
“Fungal infections of the mouth (thrush), throat, and esophagus in patients using EOHILIA may occur,” the FDA said. “EOHILIA can cause acid-related damage to the lining of the esophagus.” Some allergies may worsen when taking the drug.
The agency also warned that taking Eohilia can affect a child’s growth. “Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking EOHILIA.”
According to Takeda, the most common adverse reactions in the first study included “respiratory tract infection (13 percent), gastrointestinal mucosal candidiasis (8 percent), headache (5 percent), gastroenteritis (3 percent), throat irritation (3 percent), adrenal suppression (2 percent) and erosive esophagitis (2 percent).”
Ikuo Hirano, MD, professor of medicine at the Northwestern University Feinberg School of Medicine, said that “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 EOHILIA, 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,” Mr. Hirano added at the drug announcement.
After the FDA had initially declined to approve Eohilia, Takeda registered an impairment loss for the financial year ending March 31, 2022. Since the drug has been approved, the company intends to reverse the impairment in the fiscal year ending March 2024.
