OSAKA, Japan, and CAMBRIDGE, Mass., December 21, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.1
The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback.
“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” said Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization, Takeda. “Takeda is assessing the details of the CRL and evaluating a regulatory path forward.”
TAK-721 (budesonide oral suspension) is an oral viscous formulation of budesonide, formulated as an investigational treatment for eosinophilic esophagitis. It entered the Takeda pipeline through the company’s acquisition of Shire.
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.
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1 Hirano I, Futura GT. Gastroenterology. 2020;158(4):840-851.