As previously reported on December 20, 2019, Takeda Pharmaceutical Company Limited (“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).
The communication from the FDA included queries related to the design and labeling of the SC device. The CRL was unrelated to the clinical safety and efficacy data and conclusions from the pivotal trial supporting the BLA for Entyvio SC. It was also 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 510,000 patient-years of exposure to date.
In August, Takeda had a productive meeting with the FDA to review the Company’s latest data and to seek guidance on additional data needs required to support the approval of Entyvio SC. During the meeting, we gained clarity on data needs for the device, and we are moving forward to address them.
Continued testing of the device will take time, and as a result, we expect to potentially launch Entyvio SC for moderate to severe UC in the United States in 2022, pending FDA approval.
Takeda maintains great confidence in the future of Entyvio SC in the U.S., and strongly believes in the benefit that Entyvio SC can bring to patients who live with moderate to severe UC, pending approval. We remain committed to working with the FDA to meet patient needs with this important option. Entyvio SC has been approved in Australia, Canada, and Europe, where the product was launched in June 2020; regulatory review is ongoing in Japan, Switzerland and Israel.
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.
IMPORTANT SAFETY INFORMATION
In the U.S., please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO IV.
More information about ENTYVIO IV is available in the U.S. at www.ENTYVIOHCP.com.
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