Takeda Announces Launch of Entyvio® (vedolizumab) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis in Japan

November 7, 2018

Offers New Treatment Option for Patients with Ulcerative Colitis

Osaka, Japan, November 7, 2018 --- Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced the launch of Entyvio® (generic name: vedolizumab, development code: MLN0002) for the treatment of patients with moderately to severely active ulcerative colitis (UC) in Japan.

Takeda submitted a New Drug Application to the Japanese Ministry of Health, Labour and Welfare (MHLW) in August 2017 based on the results from Study CCT-101, a Phase 3 clinical study including 292 Japanese patients with moderately to severely active UC alongside data from the global GEMINI 1 pivotal Phase 3 clinical study of vedolizumab induction and maintenance treatment involving 895 patients with moderately to severely UC. Takeda obtained the New Drug Application Approval in July 2018.

“Entyvio has been approved in more than 60 countries worldwide and has a robust clinical and real-world evidence base,” said Masato Iwasaki, Ph.D., President of the Japan Pharma Business Unit and Director of Takeda. "Takeda is pleased to provide healthcare providers and patients with an important new treatment option for ulcerative colitis and continue our mission of delivering innovative medicines for patients living with gastrointestinal diseases.”

Overview of Entyvio

Brand name

Entyvio® for I.V. Infusion 300mg

Generic name

Vedolizumab [Genetical Recombination]

Effects / Indications

Induction and maintenance therapy for moderately to severely active ulcerative colitis (The drug should be used only in patients with inadequate response to conventional treatment.)

Dosage / Administration

The adult dose of vedolizumab (genetical recombination) for intravenous infusion is 300 mg/dose. The drug should be administered at Week 0, 2 and 6 after the initial administration at 8-week intervals thereafter.

Drug Price

Entyvio® for I.V. Infusion 300mg  274,490 yen


About Ulcerative Colitis
Ulcerative Colitis is one of the most common forms of inflammatory bowel disease (IBD), affecting over 220,000 people1 in Japan. UC is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal


1 The total of people granted medical claimant and/or registration certificates (for the treatment of UC) in 2013 (Japan Intractable Diseases Information Center website) 

(GI) tract that is often progressive in nature. UC involves the innermost lining of the large intestine and often presents with symptoms of abdominal discomfort and loose bowel movements, including blood or pus. The cause of UC is not fully understood, but recent research suggests hereditary, genetic, and environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC.

About Entyvio
Entyvio (vedolizumab) is a prescription medicine that has been approved for adults with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD) in more than 60 countries worldwide. In people with UC, there are an increased number of inflammatory white blood cells entering the mucosal lining of the bowel. The presence of these inflammatory cells can lead to the symptoms most commonly seen in people who have UC. Entyvio is designed to reduce this inflammation by blocking the movement of the white blood cells into the inflamed gut tissue. Mucosal addressing cell adhesion molecule 1 (MAdCAM-1) is preferentially expressed on the endothelial lining of blood vessels in the lymphoid tissue of the bowel. The alpha 4 beta 7 integrin is expressed on a subset of circulating white blood cells. Entyvio specifically binds to the alpha 4 beta7 integrin and blocks its interaction with MAdCAM-1, therefore inhibiting the white blood cells from entering the inflamed gut tissue, thus decreasing inflammation.

Takeda’s Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Around 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/

 


Disclaimer
The drug information contained herein is intended to disclose Takeda's corporate information. Nothing contained herein should be considered a solicitation, promotion or indication for any prescription drug including the ones under development.

Media Contacts:
JPBU Communications
Ryoko Omichi
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Media outside Japan
Luke Willats
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