Priority review sets TAK-721 up to be first FDA-approved treatment for EoE

The US Food and Drug Administration has accepted the New Drug Application submitted by Takeda Pharmaceuticals (TYO: 4502) and granted Priority Review for TAK-721 for the treatment of eosinophilic esophagitis (EoE), the Japanese drug giant announced today.

If cleared for marketing, the investigational therapy budesonide oral suspension (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 and Orphan Drug designations from the FDA.