BRIEF—FDA nod of for Takeda's US Entyvio facility

Japan’s largest drugmaker Takeda Pharmaceutical says the US Food and Drug Administration 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.

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 USA and European Union, with more than 415,000 patient years of exposure to date.

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.