Takeda Receives U.S. FDA Approval to Manufacture ENTYVIO® (vedolizumab) Drug Substance at Manufacturing Facility in Brooklyn Park, Minnesota
Cambridge, MASSACHUSETTS and Osaka, JAPAN, June 23, 2020 --- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s submission for its biologics manufacturing facility located in Brooklyn Park, Minnesota for the production of Entyvio® (vedolizumab) drug substance. The facility also has capabilities beyond production of Entyvio drug substance to support the study and development of future biologic products.
“Takeda’s focus is on providing patients access to quality therapies globally,” said Thomas Wozniewski, Global Manufacturing and Supply Officer at Takeda. “The approval for commercial production of Entyvio drug substance from Brooklyn Park will expand Takeda’s capacity to supply patients with this important product. Adding Brooklyn Park as an additional drug substance source will be essential to optimize our global efficiency and supply chain flexibility. This will allow us to sustainably support the growing demand of Entyvio to more patients in the U.S. and beyond.”
Entyvio was approved by the FDA in 2014 as a biologic therapy for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). Entyvio has been granted marketing authorization in more than 60 countries, including the United States and European Union, with more than 415,000 patient years of exposure to date.
“Entyvio is critical to Takeda’s portfolio for the treatment of patients living with gastrointestinal diseases that can be complex, debilitating and life-changing, such as ulcerative colitis and Crohn’s disease, and expanding production at Brooklyn Park demonstrates our commitment to serving patients in the US and globally,” said Uthra Sundaram, Head of Patient Value & Product Strategy, Takeda Pharmaceuticals. “Our Brooklyn Park facility is a key part of our operations and we’re pleased to manufacture Entyvio drug substance in Minnesota, a leading healthcare ecosystem in the U.S.”
Takeda worked closely with the FDA, the state of Minnesota and the City of Brooklyn Park to obtain the necessary approvals and operating permits for manufacturing and commercial production. More than $75 million in renovations and equipment have been invested in the facility to prepare it for full production.
The Brooklyn Park facility currently employs nearly 300 full-time and contract employees, and continues to hire to fill additional roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles. Takeda acquired the Brooklyn Park facility from Baxalta in 2016.
Takeda also operates six plasma collection centers employing more than 300 people in Minnesota through its subsidiary, BioLife Plasma Services.