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. 

IMPORTANT SAFETY INFORMATION

• ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
• Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
• Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
• Progressive multifocal leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the post marketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cell/mm3 and prior and concomitant immunosuppression). Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
• There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
• Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
• Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Media Contacts:

Japanese Media
Kazumi Kobayashi
[email protected]
+81 (0) 3-3278-2095

Media outside Japan
Tsuyoshi Tada
[email protected]
+1 (617) 588-8849


Please see accompanying full Prescribing Information, including Medication Guide.


About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.
For more information, visit https://www.takeda.com.

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