Takeda’s Eohilia rebounds to win FDA approval as ‘first and only’ oral therapy for EoE
Click Here to Manage Email Alerts
The FDA has approved Takeda Pharmaceuticals’ Eohilia as the “first and only oral therapy” for treatment of eosinophilic esophagitis in patients aged 11 years or older, according to a press release.
The agency had denied Takeda’s new drug application for Eohilia (budesonide oral suspension) for this indication in 2021, citing only that it could “not be approved in its present form,” and recommending additional clinical studies. In May 2022, rival drug dupilumab (Dupixent, Sanofi and Regeneron) won the race to enter the market as the first medication approved to treat EoE.
“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options,” Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the division of gastroenterology and hepatology at Northwestern University Feinberg School of Medicine, said in the release.
“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,” Hirano added. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that Eohilia offers as an oral medication.”
The agency based its decision on two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week trials (Study 1 and Study 2), respectively assessing the safety and efficacy of Eohilia in patients aged 11 to 56 years old and 11 to 42 years old with EoE. Patients in the studies either received Eohilia 2 mg or placebo twice daily for 12 weeks.
The studies’ efficacy endpoints included histologic remission (defined by peak eosinophil count of 6 per high-powered field across all available esophageal levels) and the absolute change from baseline in the Dysphagia Symptom Questionnaire (DSQ) combined score following 12 weeks of treatment.
According to the release, significantly more patients who received Eohilia achieved histologic remission compared with placebo in Study 1 (53.1% vs. 1%) and Study 2 (38% vs. 2.4%). The absolute change from baseline in the DSQ combined score in those treated with Eohilia compared with placebo was 10.2 (1.5) vs. -6.5 (1.8) in Study 1 and -14.5 (1.8) vs. -5.9 (2.1) in Study 2.
A significantly greater number of patients who received Eohilia compared with placebo either experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” during the last 2 weeks of each study, the release stated. However, Eohilia has not yet demonstrated efficacy or safety for the treatment of EoE beyond the 12 weeks of indicated treatment.
The combined common adverse reactions from the two studies included respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression and erosive esophagitis, the release noted. The safety profile of Eohilia was similar between the two trials.
“For most of us, eating is a simple experience,” Brandon Monk, senior vice president and head of the U.S. Gastroenterology Business Unit at Takeda, said in the release. “But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation. 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.”
Read more about
Click Here to Manage Email Alerts