Response to FDA denial of topical oral viscous formulation of budesonide

In December 2021, APFED reported that the U.S. Food and Drug Administration (FDA) denied the TAK-721 New Drug Application, indicating the drug – a budesonide oral suspension –  would not be approved in its present form. According to the drug developer, Takeda, the FDA had also recommended additional clinical study to address their feedback.

TAK-721 is a novel, topical oral viscous formulation of budesonide, specifically formulated to treat localized inflammation in the esophagus caused by EoE. The drug sponsor has not made public the Complete Response Letter generated by the FDA regarding its application for TAK-721.  Given the pathway laid out by FDA regarding drug approval for EoE, the fact that oral budesonide has good safety profile and is approved for use to treat EoE in other countries and approved in the U.S. to treat other GI inflammatory conditions, APFED, along with other patient advocacy groups, sent a joint communication to the FDA to express our disappointment and confusion regarding the denial, and requested the FDA reconsider their decision regarding TAK 721 and make public the explanation for its decision not to approve.

We will continue to advocate and share information as it becomes available. In the interim, we encourage you to continue to share with us your experiences with mixing budesonide slurry for treatment of eosinophilic esophagitis, so that we may share compiled feedback with the FDA.