FDA Denies Approval of Novel Budesonide Formulation for Eosinophilic Esophagitis

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Takeda regarding the New Drug Application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE).

TAK-721 is a novel mucoadherent topically active oral viscous formulation of budesonide, formulated specifically to treat localized esophageal inflammation caused by EoE. The application included data from two pivotal phase 3 studies, ORBIT1 (ClinicalTrials.gov Identifier: NCT02605837) and ORBIT2 (ClinicalTrials.gov Identifier: NCT02736409), which evaluated the efficacy and safety of TAK-721 in patients aged 11 to 55 years with EoE.

In the CRL, the FDA stated that the application could not be approved in its present form and recommended an additional clinical study in order to help resolve the issues.

“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” said Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization, Takeda. “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”

Reference

Takeda receives Complete Response Letter from the US FDA for TAK-721. News release. Takeda Pharmaceutical Company Limited. December 21, 2021. Accessed December 22, 2021. https://www.businesswire.com/news/home/20211221005772/en/Takeda-Receives-Complete-Response-Letter-from-the-U.S.-FDA-for-TAK-721.