The first Esophedritis (EoE) drug! Takeda TAK-721 (Budined oral suspension) is under FDA priority review!

December 16, 2020 // -- Takeda recently announced that the U.S. Food and Drug Administration (FDA) has accepted TAK-721's new drug application (NDA) and granted priority review.
TAK-721 is an oral suspension of Budinide, a new adhesive locally active oral adhesive preparation designed to treat eosinophilic esophagealitis (EoE).
if approved, the TAK-721 would be the first FDA-approved drug to treat the chronic inflammatory disease, and Takeda plans to sell it under the brand name Eohilia.
FDA usually gives priority to drugs that have the potential to make significant progress in terms of safety or effectiveness compared to current therapies after approval.
, the FDA has granted TAK-721 Breakthrough Drug Qualification (BTD) and Orphan Drug Qualification (ODD).
TAK-721 development project is the first and largest phase 3 clinical trial project reported in the United States.
NDA is based on data from key Phase 3 trials ORBIT1 and ORBIT2, which looked at the safety and effectiveness of TAK-721 in adolescent and adult (11-55 years old) EoE patients.
esophitis (Photo: frontiersin.org) EoE is a chronic inflammatory disease that can cause damage to the esoph way.
the United States, about one in every 2,000 people has EoE, and the prevalence of the disease is on the rise.
the exact cause is not clear, EoE involves the complex effects of genes, environmental factors, and immune system dysfunction.
inflammation of EoE can lead to a range of symptoms that may vary from person to person and age, but the most common result is difficulty swallowing.
if left untreated, EoE worsens over time and leads to eso esody injury and inflammation.
in severe cases, EoE can lead to narrow esoesosis, which can cause food to get stuck.
Asit Parikh, regional head of gastroenterology at Takeda, said:
It Parikh, head of the regional department for gastroenterology at Takeda, said: "For a long time, healthcare professionals have not had a treatment specifically developed specifically for chronic, limited esopaeditis.
we are excited about the data from key Phase 3 clinical trials that show that TAK-721 helps address inflammation in the esoesota.
are committed to working closely with the FDA to further deepen our understanding of EoE and look forward to bringing new treatment options to patients and their healthcare professionals.
() Origin: 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。