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Takeda Submits New Drug Application for a Subcutaneous Formulation of Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis in Japan.

ENPNewswire-August 9, 2019--Takeda Submits New Drug Application for a Subcutaneous Formulation of Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis in Japan

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Release date- 08082019 - Osaka - Takeda Pharmaceutical Company Limited ('Takeda') (TSE: 4502/NYSE: TAK) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC).

Takeda proposes to make vedolizumab SC available in both syringe and pen options.

'This NDA filing is an important step in our commitment to deliver innovative medicines and treatment modalities that meet the needs of patients living with ulcerative colitis in Japan,' said Naoyoshi Hirota, Head of the Takeda Development Center Japan. 'By making it possible to select the treatment modality that suits a patient's desired administration method and lifestyle, we are aiming to enhance the patient experience and help fulfill their needs.'

This NDA filing is based on the results of the VISIBLE 1 trial, a phase 3 clinical trial that evaluated the efficacy and safety of vedolizumab subcutaneous as maintenance therapy. In the VISIBLE 1 trial conducted in 216 adult patients with moderately to severely active ulcerative colitis, clinical response was obtained at week 6 following two doses of open-label intravenous administrations of vedolizumab as an induction therapy at weeks 0 and 2[i]. The results of the VISIBLE 1 trial were presented at the 2018 United European Gastroenterology Week Congress in Vienna, Austria.

In evaluating the primary endpoint of VISIBLE 1, a statistically significant proportion of patients receiving vedolizumab subcutaneous 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p1 point.

About the VISIBLE Trials

The VISIBLE clinical trial program aims to assess the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).

VISIBLE consists of three phase 3 studies involving over 1,000 UC and CD patients which includes two randomized, double-blind, placebo-controlled studies examining the proportion of patients achieving clinical remission at week 52, and an open-label extension study to determine the long-term safety and efficacy of vedolizumab SC3,4,5.

About Ulcerative Colitis

Ulcerative colitis is one of the most common forms of inflammatory bowel disease (IBD)6, affecting over 220,000 people in Japan. UC is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal (GI) tract that is often progressive in nature7,8. 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 (vedolizumab)

Vedolizumab is a gut-selective biologic and is currently approved as an intravenous formulation9. It is a humanized monoclonal antibody designed to specifically antagonize the 47 integrin, inhibiting the binding of 47 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1)10. MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract11. 47 integrin is expressed on a subset of circulating white blood cells10. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn's disease10,12,13. By inhibiting 47 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.


The drug information contained herein is intended for the disclosure of Takeda corporate information and is not intended to advertise or promote any prescription drug, including those under development.


Tomoe Honda

Tel: +81 (0) 3-3278-3448


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Publication:ENP Newswire
Geographic Code:9JAPA
Date:Aug 9, 2019
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