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
Click here to read full press release/ article | Ref: Takeda | Image: CNBC
The post Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis first appeared on PharmaShots.
