FDA accepts filing of TAK 721 for eosinophilic esophagitis.- Takeda

Takeda Pharmaceutical Co announced that the FDA has accepted for review the company’s New Drug Application (NDA) and granted Priority Review for the investigational therapy TAK 721 (budesonide oral suspension), which has been designed specifically for eosinophilic esophagitis (EoE). If approved, TAK-721 will be the first FDA-approved treatment for the chronic inflammatory disease, and Takeda plans to use the trade name Eohilia (budesonide oral suspension). The FDA grants Priority Review for medicines that, if approved, have the potential to offer significant advances in the safety or effectiveness of the current treatment approaches. TAK 721 previously received both Breakthrough Therapy designation and Orphan Drug designation from the FDA. The TAK 721 development program is the first and largest EoE Phase III clinical trial program in the U.S. to report results. The NDA filing is based on data from the pivotal Phase III trials ORBIT1 and ORBIT2, which investigated the safety and efficacy of TAK 721 in adolescent and adult patients (11 to 55 years of age) with EoE.