Takeda's EoE Drug Candidate TAK-721 (Budesonide Oral Suspension) Receives Complete Response Letter from U.S. FDA

Eosinophilic Esophagitis (Image Source: frontiersin.org)

December 21, 2021 /BioValleyBIOON/ -- Takeda Pharmaceutical Company Limited recently announced that the U.S. Food and Drug Administration (FDA) Has been targeted atTAK-721 (Budesonide Oral Suspension)The New Drug Application (NDA) issued a Complete Response Letter (CRL), the drug isA novel adhesive topical active oral viscous formulation of budesonide, specifically designed for the treatment of eosinophilic esophagitis (EoE), also known as eosinophilic esophagitis, is a chronic inflammatory disease characterized by eosinophil infiltration throughout the entire esophageal wall.

CRL stated that the FDA has completed the review of the TAK-721 NDA and determined that the NDA cannot be approved in its current form. Additionally, the FDA recommended conducting additional clinical studies to help addressFDAFeedback.

Ramona Sequeira, President of Takeda’s U.S. Business Unit and Global Portfolio Commercialization, stated: "We are disappointed with the FDA's review outcome for TAK-721, and patients with EoE still do not haveFDA"An approved safe and effective treatment regimen. Takeda is evaluating the details of the CRL and assessing the future regulatory pathway."

EoE is a chronic inflammatory disease that can cause damage to the esophagus. In the United States, approximately 1 in every 2,000 people has EoE, and the prevalence of the disease is rising. Although the exact cause is unclear, EoE involves the complex interaction of genes, environmental factors, and immune system dysfunction. The chronic inflammation associated with EoE can lead to a range of symptoms, which may vary by individual and age, but the most common result is difficulty swallowing. If left untreated, EoE can worsen over time, leading to esophageal damage and inflammation. In severe cases, EoE can cause esophageal strictures, which may result in food impaction.

The TAK-721 development program is the first and largest Phase 3 trial for EoE to report results in the United States.Clinical TrialProject. The NDA is based on data from the pivotal Phase 3 trials ORBIT1 and ORBIT2, which investigated the safety and efficacy of TAK-721 in adolescent and adult (11-55 years) patients with EoE.

Previously, the U.S. FDA had granted TAK-721 Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD). In December 2020, when the NDA was accepted,FDAAlso granted priority review to the NDA. (Bioon.com)

Source of Original Text:Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721