Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) (“Takeda”) announced today that it has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) following its New Drug Authorization Application (NDA ) for TAK-721, an oral suspension of budesonide, for the treatment of eosinophilic esophagitis, a chronic inflammatory disease of the esophagus.1
In this letter, the FDA indicates that it has completed its review of Takeda’s NDA for TAK-721 and has decided that it cannot be authorized in its current form. The FDA also recommended that Takeda conduct a new clinical study to address the issues it raised.
“We are disappointed with the findings of the FDA review of TAK-721, as is the fact that patients with eosinophilic esophagitis are still deprived of a treatment option deemed safe and effective by the FDA,” said Ramona Sequeira, President of Takeda’s US Business and Global Portfolio Marketing. “Takeda is currently reviewing the details of the response letter and determining the regulatory path forward. ”
About TAK-721 (budesonide oral suspension)
TAK-721 (budesonide oral suspension) is a viscous formulation of budesonide, administered orally and developed as an investigational treatment for eosinophilic esophagitis. This drug entered the Takeda pipeline when the company acquired Shire.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502 / NYSE: TAK) is a global, values-based, R&D-oriented biopharmaceutical leader, headquartered in Japan. Guided by its commitment to patients, its employees and the planet, the company is committed to discovering and providing life-changing treatments. Takeda focuses its R&D efforts in four therapeutic areas: oncology, rare disease genetics and hematology, neuroscience and gastroenterology. The company also makes targeted investments in R&D in the field of plasma-derived treatments and vaccines. It is primarily focused on the development of highly innovative medicines that help improve people’s lives by pushing the boundaries of new treatment options and using its enhanced collaborative R&D engine and capabilities to create a strong and diverse pipeline. Its employees are committed to improving the quality of life for patients and working with the company’s partners in the healthcare industry 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.
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