FDA Gives Priority Review for What Could be the First Therapy for Eosinophilic Esophagitis

Takeda has just announced that their application to the the FDA for their eosinophilic esophagitis (EoE)  investigative therapy has received Priority Review. This therapy is called budesonide oral suspension or TAK-721. It was created to treat the localized inflammation caused by EoE. If this therapy is approved, it will be marketed under the name Eohilia.

Priority Review is granted only to medications that could potentially offer significant improvements for patients. In instances where a medication could provide improved efficacy over current options, or would be the first treatment for a condition ever approved by the FDA, this priority status is considered.

TAK-721 has already been given Orphan Drug Designation and Breakthrough Therapy Designation for EoE by the FDA.

EoE

Eosinophilic esophagitis is a rare and chronic autoimmune condition that causes inflammation in the esophagus. While researchers are unclear on the exact cause of EoE, they believe it may be triggered by environmental allergens or some foods. Treatment depends on the cause of EoE and may include eliminating certain foods from the diet or using glucocorticosteroids or proton pump inhibitors. There is no FDA approved therapy. Symptoms of EoE include:

  • Vomiting
  • Issues swallowing
  • Heartburn

In extreme cases, patients may experience a narrowing of the esophagus due to inflammation. This may require treatment with an endoscope to remove food stuck in the organ.

TAK-721

TAK-721 is an oral therapy that was created to treat localized inflammation in EoE patients. The Phase 3 trials of this therapy (ORBIT1/ORBIT2) are the largest the U.S. has ever seen for EoE. These investigations examined both the safety and the efficacy of the treatment for patients 11- 55 years old.

If approved, TAK-721 will be the first therapy approved by the FDA to treat EoE.

You can read more about this therapy and the FDA approval process here.

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