Pharmaceutical company Takeda has announced that the US Food and Drugs Administration (FDA) has accepted its new drug application designed for eosinohilic oesophagitis (EoE), TAK-721, and granted it Priority Review.

If approved, the budesonide oral suspension will be the first EoE treatment to be approved in the US. Takeda plans to use the trade name Eohilia.

TAK-721

The drug is a novel mucoadherent topically active oral viscous formulation of budesonide. It has been specifically designed to treat the localised inflammation caused by eosinophilic oesophagitis.

Although some patients currently choose to take budesonide orally, it has always been off-label and expensive to make into a syrup. TAK-721 would be the first EoE treatment to be approved and recommended by the FDA.

Development Programme

The FDA has previously granted TAK-721 Breakthrough Therapy designation and Orphan Drug designation. Two Phase 3 trials, ORBIT1 and ORBIT2, investigated its efficacy and safety in adult and adolescent EoE patients aged 11-55.

We are enthusiastic about the pivotal Phase 3 clinical data showing the ability of TAK-721 to help address esophageal inflammation. 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 healthcare professionals.

 - Karen Lasch MD, Vice President of Gastroenterology at Takeda

It should be noted that, although promising news, Breakthrough Therapy designation, Orphan Drug designation and Priority Review do not guarantee that TAK-721 will be approved by the FDA.

Links

• Takeda press release
• ORBIT1 ClinicalTrials.gov listing
• ORBIT2 ClinicalTrials.gov listing

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