FDA accepts Takeda’s NDA, grants review for budesonide oral suspension
Takeda Pharmaceutical announced the FDA accepted its new drug application and granted priority review for TAK-721, an investigational therapy budesonide oral suspension intended for the treatment of eosinophilic esophagitis.
“EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus,” Karen Lasch, MD, vice president, gastroenterology, U.S. Medical, told Healio Gastroenterology. “If left untreated, inflammation of EoE can worsen and narrow the esophagus over time, which can lead to food impaction that may necessitate urgent endoscopic intervention. Yet, there is no FDA-approved treatment option, so physicians and patients have limited choices. We believe they deserve more. The FDA’s acceptance of Takeda’s New Drug Application and granting of Priority Review for TAK-721 brings us one step closer to potentially bringing patients and physicians a new treatment option that may help address the chronic, localized esophageal inflammation of EoE.”
According to a press release, if TAK-721 is approved, it will be the first FDA-approved treatment for EoE. Once approved, the company plans to use Eohilia as the trade name. The FDA has previously granted TAK-721 both breakthrough therapy designation and orphan drug designation.