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Eosinophilic esophitis (EoE) is an immune-mediated, chronic inflammatory disease confined to the esophine that can cause damage to the esophavius and the prevalence is increasing.
the exact cause has not been clarified, EoE involves complex interactions between genetic, environmental factors and immune system dysfunction.
inflammation of EoE can lead to a range of symptoms, most often leading to difficulty swallowing.
treatment, EoE can be aggravated over time, causing damage and inflammation to the esotherra.
severe, EoE can cause the esother to narrow, which can cause food to get stuck and require urgent endoscopic treatment.
tak-721 is a new oral adhesive formulation from Budinard that adheres locally to the mucous membrane, thereby producing activity at the esota and is a specially designed formulation for EoE.
is a glucosticoid whose other formulation types have been used to treat inflammatory diseases such as asthma, chronic obstructive pulmonary disease, allergic rhinitis and nasal pneumo meat.
the NDA application is based on data from key Phase 3 clinical trials ORBIT1 and ORBIT2, which studied the safety and efficacy of TAK-721 in adolescent and adult EoE patients (11-55 years old).
results showed that TAK-721 significantly improved the patient's histological response rate and significantly reduced the count of eosinophils.
: U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda's TAK-721 (budesonide oral class) for The Treatment of Eosinophilic Esophagitis. Retrieved December 15, 2020, from。