Japanese biopharmaceutical company Takeda recently announced an important update. This update concerns the FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Eosinophilic Oesophagitis (EoE) Treatment.

The FDA accepted the previous drug application for review but later turned it down, causing widespread disappointment within the eosinophilic community.

The resubmission considers prior FDA feedback and aims for a more favourable outcome this time.

“Takeda’s focus on TAK-721 is driven by our belief that there are significant unmet treatment needs in the EoE community,” said Vijay Yajnik, M.D., Ph.D., vice president, head of U.S. Medical for Gastroenterology, Takeda. “Over the past several months, we’ve reanalyzed the TAK-721 clinical data and pursued a dialogue with the FDA because we recognize EoE patients need additional therapeutic options. As a result of that constructive discussion, we have resubmitted our NDA with a revised proposed indication, for short-term treatment of EoE.”

Takeda expects a decision from the FDA during the first half of 2024.

About TAK-721 (Budesonide Oral Suspension)

TAK-721 is a uniquely formulated, mucoadhesive, topically active oral viscous form of budesonide. It has been developed specifically for investigative use in treating eosinophilic oesophagitis (EoE). The suspension targets the local inflammation in the oesophagus caused by EoE.

About Eosinophilic Oesophagitis (EoE)

Eosinophilic Oesophagitis (EoE) is the most common of the eosinophilic gut disorders, affecting around 1 in 1,500 people.

Sometimes referred to as ‘Oesophageal Asthma,’ it goes by the spelling ‘Eosinophilic Esophagitis’ in the United States and Canada. 

EoE is a long-term condition that impacts the oesophagus - the tube linking the mouth to the stomach.

An excess of eosinophils, a variety of white blood cells, leads to oesophageal inflammation, complicating the act of swallowing. Additional symptoms can range from food aversion in children to heartburn and vomiting in adults. The symptoms can vary from person to person but significantly affect the quality of life.

What This Means For The Eosinophilic Community

There is a significant gap in treatment options for EoE within our community. 

The need to rely on off-label DIY medications has raised safety concerns and added the complexity of managing correct dosages and consistency. 

The lack of approved medications has also meant that community guidelines for treatment are often unclear or insufficient, leaving many frustrated in managing their condition.

The recent announcement from Takeda comes as an encouraging development. Should the medication gain approval in the US, it would be a milestone, providing another FDA-approved treatment specifically designed for EoE. 

Not only could this alleviate some of the burden faced in finding appropriate treatments, but it could also pave the way for effective treatment options for our community.

This news opens up a more hopeful dialogue about the future, given that several other EoE treatments are also in the pipeline. 

With increased focus and investment from pharmaceutical companies, we can be more optimistic about a future where EoE can be managed more effectively, safely, and conveniently.

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