CAMBRIDGE, Massachusetts, October 28, 2021 – As previously reported on December 20, 2019 and updated on September 1, 2020, Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the submission of a Biologics License Application (BLA) for an investigational subcutaneous (SC) formulation of Entyvio® (vedolizumab) for maintenance therapy in adults with moderate to severe ulcerative colitis (UC).
Through our ongoing interactions with the FDA, Takeda has received feedback which has provided clarity on the regulatory package and critical elements for the resubmission of the BLA for Entyvio SC as maintenance therapy in adults with moderate to severe ulcerative colitis, and we are moving forward accordingly. We are reviewing our development program timelines and currently anticipate potential approval in FY 2023.
Communications with the FDA have been related to the design and labeling of the SC device and are not related to the clinical safety and efficacy data and conclusions from the pivotal trial supporting the BLA for Entyvio SC. They have also been unrelated to the intravenous (IV) formulation of Entyvio, which has been granted marketing authorization in 71 countries, including the United States and European Union, with more than 740,000 patient-years of exposure to date.1
Takeda maintains great confidence in the future of Entyvio SC in the U.S. and strongly believes in the benefit it can bring to patients who live with moderate to severe UC. We remain committed to working with the FDA throughout the review and approval process to meet patient needs with this important option. Entyvio SC has been approved in Argentina, Australia, Canada, Kazakhstan, Switzerland, the United Arab Emirates, and Europe, where the product was launched in June 2020.
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
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 Takeda data on file (VV-SUP-91507): Vedolizumab Patient Exposure from Marketing Experience. 2021.