Takeda India, part of the Takeda Pharmaceutical Company Limited, a global values-based R&D-driven biopharmaceutical leader, has announced the expansion of its highly innovative portfolio for patients in the country with the launch of Kynteles®(generic name: Vedolizumab) as part of its Gastrointestinal (GI) portfolio. GI is Takeda’s second therapeutic area in India after Rare diseases (Haematology, Genetic diseases, and Immunology).[3]

Kynteles®is used for the treatment of adult patients with moderate to severely active Ulcerative Colitis (UC) and Crohn’s Disease (CD). Kynteles®, more widely known as Entvyio®, has shown favourable safety and efficacy results in treating patients suffering from moderate to severe IBD[4],[5],[6].

Speaking about the launch, Koki Sato, Country Head, Takeda India, said,”At Takeda, we are continuously working towards developing innovative medicines to considerably improve the quality of life of patients. The launch of our highly innovative GI portfolio is a testimony of our commitment to India and patients living with diseases like UC and CD. Patient access to Kynteles® will further augment our vision of providing additional and innovative treatment options to HCPs treating UC and CD.”

Both UC and CD are chronic idiopathic Inflammatory Bowel Diseases that can be debilitating and sometimes lead to life-threatening complications and require life-long disease management. Therefore, their treatments involve ensuring long-term remission with a proven safety profile. Entyvio®is currently marketed in more than 60 countries. In just five years since its global launch, Entyvio® has touched over 415,000 cumulative patient-years of experience.¹²

Talking about Kynteles®, Dr.Sandeep Arora, Medical Affairs Head, Takeda India, said,”India has the highest burden of IBD in Asia and one of the highest in the world as a result of rapid urbanization, changes in diet and lifestyles. Kynteles®, with its novel mechanism of action, selectively reduces intestinal inflammation that allows long-lasting remission and provides a safe and effective treatment option for patients with UC and CD. The safety and efficacy of Kynteles®is well established and proven through robust and comprehensive clinical trials and large real-world evidence programs. Evidence also suggests improved quality of life without an associated increase in overall risk of infection.” There are currently over 1.5 million IBD patients in India.

About Kynteles®®

Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation.[7] It is ahumanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting thebinding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), butnot vascular cell adhesion molecule 1 (VCAM-1).[8] MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.[9] The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.¹⁰ These cells have been shown to play a role in mediating the inflammatory process inulcerative colitis (UC) and Crohn’s disease (CD).[10], [11] By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.¹¹

Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD,who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα)-antagonist. Vedolizumab IV has been granted marketing authorization in over 60 countries, including the United States and European Union, with more than 415,000 patient years of exposure to date.[12]

Therapeutic Indications

Ulcerative colitis: Kynteles® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Crohn’s disease: Kynteles® is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

Kynteles® treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn’s disease, and to be sold by retail on the prescription of a Registered Gastroenterologist only. Patients, on Kynteles®, should be given the package leaflet and the Patient Alert Card.

 [2]Kedia S et al. Epidemiology of Inflammatory Bowel Disease in India: The Great Shift East..InflammIntest Dis, 2017. DOI: 10.1159/0004655222017

[3]https://www.takeda.com/en-be/what-we-do/rare-diseases/

[7]European Medicines Agency. Entyvio EPAR product information. EMEA/H/C/002782 – IB/0030 ANNEX 1

Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/entyvioepar-

product-information_en.pdf. Last updated: April 1, 2019. Last accessed: September 2019.

[8]Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875.

[9]Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97-110.

[10]Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298-1312.

[11]Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444.

[12] Takeda. Data on file. 2019

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Delhi, 01April, 2020: Takeda India has  appointed Koki Sato as the country head for the company’s India business. In his current capacity, he will lead the company’s operations with a focus on the expansion of patient access to Takeda’s highly innovative portfolio in the country.

Koki  joined Takeda in 2003 and,since then, grew within the company to hold various senior international roles across multiple functions, including commercial operations, finance, and HR.prior to this role, Koki was the General Manager of Ukraine, Belarus, and Moldova (UBM) Cluster in Takeda’s ICMEA* Area.

Commenting on his new role, Koki Sato said, “India is of significant importance for Takeda and we endeavor to develop initiatives which will lead to enhanced patient access to our highly innovative medicines locally. We remain committed to serving India’s patients ,and aim to bring newer  therapies for rare diseases, gastroenterology, and oncology to them in the coming years, along with hopefully, our Dengue vaccine candidate.”

 Across its ICMEA* Area, and more broadly across the countries that span its Growth & Emerging Markets Business Unit, Takeda collaborates with healthcare providers, governments and regulators, to ensure that its portfolio of innovative medicines is made available to patients as quickly and safely as possible.

 Koki will be officially assuming his position from April 1, 2020. He is a Japanese national and holds a Bachelor of Arts degree in Political Science and Economics from Waseda University, Japan.

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