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Takeda Reports the US FDA's Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

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Takeda Reports the US FDA's Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Shots:

  • The US FDA has accepted the NDA and granted PR for TAK-721 for the treatment of EoE. If approved- TAK-721 will be the first FDA-approved treatment for EoE and Takeda plans to launch it under the trade name Eohilia
  • The NDA filing is based on P-III ORBIT-1 and ORBIT-2 studies which evaluated the safety and efficacy of TAK-721 in adolescent and adult patients (11-55 yrs. of age) with EoE
  • TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide and has earlier received the US FDA’s BT and ODD

 ­ Ref: Takeda | Image: Takeda

Click here to­ read the full press release 

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