FDA Denies Approval of New Budesonide Formulation for Eosinophilic Esophagitis


The Food and Drug Administration (FDA) has sent Takeda a Complete Response Letter (CRL) regarding the new drug request for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE).

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

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

“We are disappointed with the outcome of the FDA review of TAK-721 and that EoE patients will still not have a treatment option that the FDA has approved as safe and effective,” said said Ramona Sequeira, President of the US Business Unit and Global Portfolio. Marketing, Takeda. “Takeda is evaluating the details of the CRL and evaluating a regulatory path forward. “

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Takeda receives full response letter from US FDA for TAK-721. Press 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-US-FDA-for-TAK-721.

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