The FDA accepted Takeda's new drug application for TAK-721, its eosinophilic esophagitis treatment, the company announced Dec. 15.
The FDA also granted the treatment priority review. If approved, the treatment will be the first such treatment for the chronic inflammatory disease.
TAK-721 is an investigational therapy budesonide oral suspension. The FDA previously granted it breakthrough therapy designation and orphan drug designation.
EoE is a chronic inflammatory disease that damages the esophagus. The disease affects 1 out of every 2,000 Americans, with increases expected. The exact cause of the disease remains unknown.
The drug is currently in the middle of the largest EoE phase 3 clinical trial program in the U.S.