Takeda’s Novel Budesonide Oral Suspension TAK-721 Receives FDA Priority Review as Potential First-Ever Therapy for Eosinophilic Esophagitis

Takeda Announces FDA Acceptance of New Drug Application for Investigational Oral Budesonide Suspension TAK-721 for Eosinophilic Esophagitis (EoE), Granting Priority ReviewTakeda Pharmaceutical Company Limited announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for TAK-721, an investigational oral budesonide suspension, for the treatment of eosinophilic esophagitis (EoE). The FDA has also granted priority review designation to this NDA. According to the press release, if approved, TAK-721 would become the first FDA-approved therapy for EoE, a chronic inflammatory disease. TAK-721 had previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA.

Eosinophilic Esophagitis (EoE) is an immune-mediated, chronic inflammatory disease confined to the esophagus that can cause esophageal damage, and its prevalence is increasing. Although the exact etiology remains unclear, EoE involves a complex interplay of genetic, environmental factors, and immune system dysfunction. The chronic inflammation associated with EoE can lead to a range of symptoms, most commonly dysphagia. If left untreated, EoE can worsen over time, causing progressive damage and inflammation to the esophagus. In severe cases, EoE can lead to esophageal stricture, which may result in food impaction requiring urgent endoscopic intervention.

TAK-721 is a novel oral viscous formulation of budesonide, designed specifically for eosinophilic esophagitis (EoE). It locally adheres to the mucosa, thereby exerting its therapeutic effect in the esophagus. Budesonide is a glucocorticoid whose other formulations have been used to treat inflammatory conditions such as asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis, and nasal polyps.

▲ Molecular structure of budesonide (Image source: JenWei, CC0, via Wikimedia Commons)

This NDA application is based on data from the pivotal Phase 3 clinical trials, ORBIT1 and ORBIT2, which evaluated the safety and efficacy of TAK-721 in adolescent and adult patients (aged 11–55 years) with eosinophilic esophagitis (EoE). The trial results demonstrated that TAK-721 significantly improved histologic response rates and substantially reduced eosinophil counts.

References:

[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. Retrieved December 15, 2020, from https://www.businesswire.com/news/home/20201215005640/en

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