The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) and granted Priority Review to TAK-721 (budesonide oral suspension; Takeda) 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 NDA submission is supported by data from 2 pivotal phase 3 studies (ORBIT1 and ORBIT2) that evaluated the efficacy and safety of TAK-721 in patients aged 11 to 55 years with EoE.

In ORBIT1, 318 patients were randomized 2:1 to receive 2mg of TAK-721 or placebo twice daily for 12 weeks. The co-primary end points were histologic response and dysphagia symptom response after an initial 12 weeks of therapy.

Results showed a significantly greater proportion of patients with histologic response and dysphagia symptom response in the TAK-721 group compared with the placebo group (53.1% vs 1.0%, <.001; 52.6% vs 39.1%, =.024, respectively). Significantly greater improvements were also observed with TAK-721 on key secondary end points, including the mean Dysphagia Symptom Questionnaire (-13.0 vs -9.1; =.015) and EoE Endoscopic Reference Score (-4.0 vs -2.2; <.001), compared with placebo.

Additionally, ORBIT2, a double-blind extension study, assessed the maintenance of efficacy for TAK-721 in patients with EoE who successfully completed the ORBIT1 study.

“We are enthusiastic about the pivotal phase 3 clinical data showing the ability of TAK-721 to help address esophageal inflammation.” said Asit Parikh, MD, PhD, Head, Gastroenterology Therapeutic Area Unit, Takeda. “We’re committed to working closely with the FDA to further our collective understanding of EoE, and potentially bringing a new treatment option to patients and their health care professionals.”

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1.    U.S. Food and Drug Administration accepts New Drug Application for review, grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis. [press release]. Osaka, Japan: Takeda; December 15, 2020. 

2.    First-ever U.S. pivotal phase 3 clinical study in eosinophilic esophagitis (EoE) completes: Takeda’s investigational therapy meets co-primary & key secondary efficacy endpoints. [press release]. Lexington, MA: Takeda; October 28, 2019.