Eohilia FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 13, 2024.
FDA Approved: Yes (First approved February 9, 2024)
Brand name: Eohilia
Generic name: budesonide
Dosage form: Oral Suspension
Previous Name: TAK-721
Company: Takeda Pharmaceutical Company Limited
Treatment for: Eosinophilic Esophagitis
Eohilia (budesonide oral suspension) is a mucoadherent formulation of the approved corticosteroid budesonide used for the treatment of eosinophilic esophagitis.
- Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disease that can cause damage to the esophagus. Symptoms include esophageal inflammation, vomiting, pain, dysphagia (difficulty swallowing), chest pain, and a choking sensation. In severe cases, the inflammation can lead to narrowing of the esophagus, which can cause food impaction (when food becomes stuck in the esophagus).
- Eohilia is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis. Eohilia has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
- Corticosteroids such as budesonide have been widely used in the past for the treatment of EoE, but in an off-label capacity and using multiple delivery options.
- Budesonide was first approved by the FDA under the brand name Pulmicort in 1997 as an oral inhalation formulation for the treatment of asthma. It has also been approved in delayed or extended-release oral formulations under the brand names Entocort ER for the treatment of Crohn's disease, Uceris for the treatment of ulcerative colitis, and Tarpeyo to reduce the loss of kidney function in immunoglobulin A nephropathy.
- Eohilia is a mucoadherent, topically active, oral viscous formulation of budesonide that works to treat the localized esophageal inflammation that is caused by EoE.
- FDA approval of Eohilia was based on efficacy and safety data from two placebo-controlled studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE. After 12 weeks of treatment, more patients receiving Eohilia achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%) and Study 2 (38% vs. 2.4%). During the last two weeks of each study, more patients receiving Eohilia experienced no dysphagia or only experienced dysphagia that "got better or cleared up on its own" as compared to placebo.
- Eohilia is a cherry-flavored, viscous suspension that is administered orally, twice daily for 12 weeks.
- Warnings and precautions associated with Eohilia include hypercorticism and adrenal axis suppression, immunosuppression and increased risk of infection, worsening signs or symptoms of erosive esophagitis, reduction in growth velocity in pediatric patients, symptoms of steroid withdrawal in patients transferred from other systemic corticosteroids, other corticosteroid effects (including hypertension and diabetes mellitus), and Kaposi’s Sarcoma.
- Common adverse reactions include respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.
Development timeline for Eohilia
Further information
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