FDA Approves Takeda’s Subcutaneous Ulcerative Colitis mAb

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id="main-content"> <div class="resource-single"> <div class="header bg-primary-light"> <div class="container-wrapper"> <div class="wide-container header-container"> <div class="header-content flex-1"> <div class="heading-smallcaps"> Antibody & Protein Engineering | Industry Spotlights & Insight Articles </div> <h1 class="heading"> FDA Approves Takeda’s Subcutaneous Ulcerative Colitis mAb </h1> <div class="byline"> Edited by Tom Cohen | 29 September 2023 </div> <div class="abstract"> The company can now sell their biologic for ulcerative colitis in a subcutaneous form on the US market. </div> </div> <div class="header-graphic flex-1"> <img src="https://oxfordglobal.com/hubfs/Website/Images/Resources/Biologics/Tom-Industry-Spotlight-Template-3.jpg" class="header-graphic-image"> </div> </div> </div> </div> <div class="container-wrapper"> <div class="wide-container"> <div class="content"> <div class="content-body text-gap">  <p>Takeda has announced that its single-dose pen for ENTYVIO® (vedolizumab) – a monoclonal antibody medication for ulcerative colitis – has been approved by the as a treatment for the chronic inflammatory gut disease.</p>   <p>The pen is able to deliver the drug via subcutaneous injection and is approved for adults in the US with moderate to severe cases of the condition after an intravenous course of ENTYVIO.</p>   <p><strong>RELATED:</strong></p>   <ul> <li><a href="https://oxfordglobal.com/biologics/resources/rani-strengthens-partnership-with-celltrion-to-develop-adalimumab-humira-biosimilar/" target="_blank" rel="noreferrer noopener">Rani Strengthens Partnership with Celltrion to Develop Adalimumab (Humira) Biosimilar</a></li>   <li><a href="https://oxfordglobal.com/biologics/resources/f-star-and-takeda-collaborate-to-pave-the-way-for-next-generation-cancer-therapies/" target="_blank" rel="noreferrer noopener">F-star and Takeda Collaborate to Pave the Way for Next-Generation Cancer Therapies  </a></li>   <li><a href="https://oxfordglobal.com/biologics/resources/revolutionizing-biologics-challenges-innovations-oligonucleotide-synthesis/" target="_blank" rel="noreferrer noopener">Revolutionizing Biologics: Unveiling the Challenges and Innovations in Large-Scale Oligonucleotide Synthesis </a></li> </ul>   <p></p>   <p>Takeda’s Senior Vice President and Head of their US Gastroenterology Business Unit, Brandon Monk, said: “ENTYVIO is the only FDA-approved biologic for maintenance therapy in ulcerative colitis offering the option of either intravenous or subcutaneous administration.”</p>   <p>After the encouraging news of its approval, it is predicted that subcutaneous ENTYVIO will be sold in the US by the end of October 2023.</p>   <h1 id="h-about-entyvio-vedolizumab-and-its-visible-1-trial">About ENTYVIO® (vedolizumab) and its ‘VISIBLE 1’ Trial</h1>   <p>The humanised antibody vedolizumab is an antagonist of alpha4beta7 integrin which is expressed on select T cells. By inhibiting these lymphocytes via the alpha4beta7 integrin pathway, vedolizumab stops them from infiltrating gut tissues.</p>   <p>The approval by the FDA comes after Takeda’s ‘VISIBLE 1’ phase III clinical trial of the subcutaneous administration of vedolizumab for ulcerative colitis. The trial enrolled 162 patients who either tool 108mg of vedolizumab subcutaneously or a placebo every two weeks.</p>   <p>Results from the study saw 46% of non-placebo patients achieving clinical remission by the 52<sup>nd</sup> week, while only 14% of patients from the placebo group achieved clinical remission.</p>   <p>“The VISIBLE 1 trial demonstrated that ENTYVIO SC (subcutaneous) can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients,” said Bruce Sands, Chief of the Dr Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai. Both intravenous and subcutaneous forms of the biologic are now approved in the US, EU, and over 50 further countries. Takeda already has marketing authorisation for the intravenous administration in over 70 countries, including the US and EU, it said.</p>   <p><em>Get your weekly dose of industry news and announcements </em><a href="https://oxfordglobal.com/biologics/news/" target="_blank" rel="noreferrer noopener"><em>here</em></a><em>, or head over to our </em><a href="https://oxfordglobal.com/biologics/" target="_blank" rel="noreferrer noopener"><em>Biologics portal</em></a><em> to catch up with the latest advances in targeted therapies. To learn more about our upcoming Biologics UK conference, </em><a href="https://oxfordglobal.com/biologics-series/" target="_blank" rel="noreferrer noopener"><em>visit our event website</em></a><em> to download an agenda and register your interest.</em></p>  <div class="content-body-footer"> </div> </div> <div class="content-sidebar"> <div class="related-articles"> <h3 class="center">Related Resources</h3> <div class="article"> <a href="/nextgen-biomed/resources/case-studies/accelerating-biologics-discovery-and-development"> <div class="cover-graphic"> <img src="https://oxfordglobal.com/hubfs/Website/Images/Resources/Biologics/Antibodies%20Case%20Study%20Report%20Websize.jpg" class="cover-graphic-image"> </div> </a><div class="content"><a href="/nextgen-biomed/resources/case-studies/accelerating-biologics-discovery-and-development"> <h4> Accelerating Biologics Discovery & Development Through Transformative Technologies & Overcoming Strategic Challenges </h4> <div class="abstract"> A 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FDA Approves Takeda’s Subcutaneous Ulcerative Colitis mAb