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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 | Press Release

Related News:- Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum

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