The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)
Shots:
- The approval was based on the results from 2 trials (Study 1) & (Study 2) evaluating the safety & efficacy of Eohilia (2mg, BID) vs PBO in patients (aged 11-56yrs. & 11-42yrs.) with EoE. The efficacy endpoints of the trials were histologic remission & change from baseline in patient-reported DSQ post 12wks of treatment
- The results depicted that 53.1% vs 1% & 38% vs 2.4% of patients achieved histologic remission whereas the absolute change from baseline in DSQ combined score were -10.2 vs -6.5 & -14.5 vs -5.9. It was also seen that Eohilia was not safe & effective as EoE treatment for longer than 12wks.
- Eohilia (corticosteroid) expected to be made available in 2mg/10mL dosage by the end of Feb 2024
Ref: Takeda | Image: Takeda
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
