Entyvio Manufacturer – About Takeda Oncology

Takeda Pharmaceutical Company Limited is one of the world’s most established and globally recognized biopharmaceutical leaders. Headquartered in Japan and operating in more than 80 countries, Takeda is known for its long-standing commitment to research-driven innovation in fields such as oncology, gastroenterology, neuroscience, and rare diseases. The company’s focus extends beyond developing new medicines. They aim to improve the lives of patients through science rooted in compassion and purpose.

Among Takeda’s most notable therapies is Entyvio (vedolizumab). It is a biologic medication that targets gut-specific inflammation in people with ulcerative colitis and Crohn’s disease. While Entyvio belongs to Takeda’s gastroenterology portfolio, another major pillar of the company’s work lies within Takeda Oncology. This division is dedicated to transforming cancer care through cutting-edge research and targeted therapies.

This article takes a closer look at Takeda Oncology: its mission, innovations, and how its pioneering approach continues to redefine treatment possibilities and improve outcomes for patients around the world.

Key Takeaways

• Takeda Pharmaceutical Company Limited was founded in 1781. While their headquarters are in Tokyo, they operate in over 80 countries. Their popularity makes Takeda one of Japan’s leading global biopharmaceutical firms by revenue.
• The company’s six core therapeutic areas are Gastrointestinal and Inflammation, Rare Diseases, Plasma-Derived Therapies, Oncology, Neuroscience, and Vaccines.
• Entyvio (vedolizumab), developed and commercialized by Takeda, is a gut-selective biologic used for ulcerative colitis and Crohn’s disease.
• Takeda’s subcutaneous (SC) Entyvio formulation is now FDA-approved and commercially available for maintenance therapy in adult UC (since September 2023) and Crohn’s disease (since April 2024).
• U.S. patents through May 2, 2032 protect Entyvio’s patents, providing a strong foundation before potential biosimilar competition.
• EntyvioConnect, Takeda’s patient support program, offers co-pay assistance, treatment guidance, and nurse-led support to improve therapy access and adherence.
• Clinical trials like GEMINI 1 and 2 demonstrated Entyvio’s efficacy in achieving durable remission, mucosal healing, and corticosteroid-free remission, supported by long-term real-world data.

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Takeda’s Background and Strategy in Gastroenterology / Oncology

Takeda Pharmaceutical Company Limited, founded in 1781, is one of Japan’s most established biopharmaceutical companies recognized around the world. Headquartered in Tokyo and operating in more than 80 countries, Takeda consistently ranks among Japan’s top pharmaceutical firms by revenue and global reach. Its strategy blends cutting-edge science with a strong commitment to patient-centered care, focusing on therapies that address complex, chronic, and often rare conditions.

Takeda’s six core therapeutic areas include Gastrointestinal and Inflammation, Rare Diseases, Plasma-Derived Therapies, Oncology, Neuroscience, and Vaccines. In gastroenterology, the company has earned worldwide recognition through its development of Entyvio (vedolizumab), a biologic therapy that targets gut-selective inflammation in ulcerative colitis and Crohn’s disease. This success reflects Takeda’s long-standing expertise in mucosal immunology and its deep understanding of the gut–immune axis.

Beyond Entyvio, Takeda continues to expand its GI and inflammation portfolio, exploring next-generation biologics and oral treatments designed for precision and convenience. At the same time, Takeda Oncology remains a cornerstone of the company’s innovation strategy, developing monoclonal antibodies, targeted therapies, and personalized treatments for cancer. Together, these two divisions embody Takeda’s approach: advancing science that not only manages symptoms but also reshapes disease progression and improves long-term patient outcomes.

Development History and Clinical Sponsorship of Entyvio by Takeda

Takeda’s journey with Entyvio began in 2008, when it acquired Millennium Pharmaceuticals, gaining the development rights to vedolizumab, the molecule behind the brand. This acquisition marked a turning point in Takeda’s evolution toward specialty care and biologic innovation.

Under Takeda’s leadership, Entyvio underwent extensive clinical evaluation, most notably in the GEMINI 1 and GEMINI 2 trials, which demonstrated its efficacy and safety in treating moderately to severely active ulcerative colitis and Crohn’s disease. The pivotal data showed that vedolizumab could induce and maintain clinical remission, promote mucosal healing, and achieve corticosteroid-free remission. These findings are later supported by long-term extension studies and real-world data.

Milestones in Entyvio’s Development

• Early Research: Identification of vedolizumab’s α4β7 integrin blockade as a gut-selective mechanism, minimizing systemic immune suppression.
  
• Regulatory Approvals: U.S. FDA approval in 2014, followed by authorization in more than 60 countries.
  
• Expanded Indications: Ongoing studies for additional immune-mediated disorders and alternative administration routes.

Throughout clinical development, Takeda retained full sponsorship, overseeing trial design, data integrity, and global regulatory submissions. Its transparent approach to bioethics and pharmacovigilance remains central to maintaining patient trust. For a closer look at its scientific foundation, understanding Entyvio’s generic name reveals the precision-engineered biologic molecule behind this trusted therapy.

Post-Marketing, Pharmacovigilance, and Support Programs from Takeda

After Entyvio’s global launch, Takeda implemented a comprehensive pharmacovigilance framework to monitor safety and performance in real-world use. This continuous surveillance system collects and evaluates data from healthcare providers and patients worldwide. They make sure to promptly address any potential safety concerns and share these transparently with regulatory authorities.

To further support patients, Takeda operates EntyvioConnect, a dedicated assistance program offering co-pay support, insurance navigation, nurse-led education, and treatment adherence resources. By reducing financial and logistical barriers, the program helps patients start and stay on therapy with confidence.

Takeda also collaborates with healthcare professionals through training programs, digital clinical tools, and post-marketing studies that refine Entyvio’s use in everyday practice. These initiatives demonstrate the company’s enduring commitment to ethical responsibility, education, and patient empowerment, reinforcing Takeda’s reputation as a partner in long-term disease management.

Takeda’s Pipeline, Innovation, and Competition around Entyvio

Takeda continues to invest in research that strengthens Entyvio’s clinical leadership in inflammatory bowel disease (IBD). One of its major milestones was the introduction of Entyvio’s subcutaneous (SC) formulation, now fully approved and commercially available in the United States for maintenance therapy in adults with ulcerative colitis (since September 2023) and Crohn’s disease (since April 2024). This advancement provides patients with a more convenient, self-administered option that complements the existing intravenous (IV) formulation.

In a competitive biologics market, Takeda continues to differentiate Entyvio through strong efficacy evidence from the GEMINI program and subsequent real-world studies showing durable clinical remission, mucosal healing, and steroid-free control of disease. While the company faces emerging competition from new biologics and future vedolizumab biosimilars, Takeda’s intellectual property portfolio offers substantial protection. Their U.S. patents extend through May 2, 2032.

Takeda’s continued investment in gastroenterology, oncology, and immunology pipelines demonstrates its dual commitment to innovation and long-term patient safety. As biosimilar development progresses, the company’s rigorous quality standards, data transparency, and global pharmacovigilance will continue to preserve Entyvio’s trust and reliability in the marketplace.

Conclusion

The Entyvio manufacturer, Takeda Pharmaceutical Company, represents a blend of scientific excellence, clinical integrity, and patient-first values. From early biologic research to worldwide commercialization, Takeda has upheld the highest standards of innovation, ethics, and safety.

Entyvio’s success is built not only on its clinical efficacy but also on the transparency and trustworthiness of the company behind it. Through robust safety systems, global support programs like EntyvioConnect, and a forward-looking research pipeline, Takeda continues to shape the next generation of biologic therapies.

As the landscape of IBD treatment evolves, Takeda’s leadership ensures that Entyvio remain grounded in science, compassion, and global patient care.

FAQs

1. Who is the Entyvio manufacturer?

Takeda Pharmaceutical Company Limited. It is a Japan-based global biopharmaceutical firm with expertise in gastroenterology, oncology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

2. What role did Takeda play in Entyvio’s development?

Takeda led all phases of Entyvio’s research and development, from early discovery through global regulatory approval and commercialization. They did this to guarantee adherence to ethical, scientific, and safety standards throughout.

3. Does Takeda provide patient support programs for Entyvio?

Yes. Takeda operates EntyvioConnect, a support program offering co-pay assistance. They also offer treatment education, and dedicated nurse guidance to help patients access and maintain therapy.

References

Takeda Pharmaceutical Company Limited. 2023 Annual Integrated Report. Tokyo, Japan: Takeda Pharmaceutical Company Limited; 2023. https://www.annualreports.com/HostedData/AnnualReportArchive/t/NYSE_TAK_2023.pdf

Takeda Pharmaceutical Company Limited. Takeda Announces the Publication of its Annual Report on Form 20-F for FY2023. Osaka, Japan: Takeda Pharmaceutical Company Limited; 2024. https://www.takeda.com/newsroom/newsreleases/2024/annual-report-20f-fy2023/

European Commission Approves Subcutaneous Formulation of Entyvio (vedolizumab) for Use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease. Business Wire. May 7, 2020. Accessed October 20, 2025. https://www.businesswire.com/news/home/20200507006248/en/European-Commission-Approves-Subcutaneous-Formulation-of-Entyvio-Vedolizumab-for-use-as-Maintenance-Therapy-in-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis-or-Crohns-Disease

Stansfield C. Vedolizumab (Entyvio) in Crohn’s disease. Gastrointestinal Nursing. 2021;19(6):20-26. doi:10.12968/gasn.2021.19.6.20