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.
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