FDA Denies Takeda’s New Drug Application for Esophagitis Therapy

The FDA has declined to approve Takeda Pharamceutical’s new drug application for TAK-721, developed to treat a chronic inflammatory disease of the esophagus known as eosinophilic esophagitis.

In its Complete Response Letter (CRL), the FDA said it can’t clear the drug in its current form and requested that Takeda conduct an additional study ― considerably delaying the company’s timeline for a prospective U.S. launch.

TAK-721, an oral suspension of budesonide, was acquired by Takeda during its $62 billion acquisition of Dublin, Ireland-based Shire in 2019.