{"id":752032,"date":"2023-04-27T08:56:38","date_gmt":"2023-04-27T12:56:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-c\/"},"modified":"2023-04-27T08:56:38","modified_gmt":"2023-04-27T12:56:38","slug":"takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-c","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/takeda-announces-fda-acceptance-of-bla-resubmission-for-investigational-subcutaneous-administration-of-entyvio-vedolizumab-for-maintenance-therapy-in-moderately-to-severely-active-ulcerative-c\/","title":{"rendered":"Takeda Announces FDA Acceptance of BLA Resubmission for Investigational Subcutaneous Administration of Entyvio\u00ae (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis"},"content":{"rendered":"

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Takeda Announces FDA Acceptance of BLA Resubmission for Investigational Subcutaneous Administration of Entyvio\u00ae <\/sup>(vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis<\/b><\/p>\n

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nTakeda (<\/b>TSE:4502\/NYSE:TAK<\/b><\/a>) <\/b>(\u201cTakeda\u201d) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio\u00ae<\/sup> (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous. The resubmission is intended to address FDA feedback in a December 2019 Complete Response Letter (CRL).<\/p>\n

\n\u201cTakeda has remained committed to the pursuit of a subcutaneous administration for Entyvio in the U.S. so that patients might have a choice between receiving Entyvio maintenance therapy via intravenous infusion by a health care professional or administering it themselves with a single-dose injection \u2013 whichever suits their medical and personal needs. This resubmission is a major step forward in delivering on that commitment,\u201d said Vijay Yajnik, M.D., Ph.D., vice president, head of U.S. Medical for Gastroenterology, Takeda. \u201cWe have great confidence in the future of Entyvio SC and strongly believe that offering a SC formulation can help meet the varied needs of patients who live with moderate to severe ulcerative colitis, pending approval.\u201d<\/p>\n

\nSince receiving the CRL Takeda has worked closely with the FDA to address the Agency\u2019s feedback; this resubmission package includes additional data collected to investigate the use of subcutaneous administration of Entyvio. The contents of the letter were unrelated to the intravenous (IV) formulation of Entyvio, the clinical safety and efficacy data, and conclusions from the pivotal VISIBLE 1 trial supporting the Entyvio SC BLA.<\/p>\n

\nVISIBLE 1 assessed the safety and efficacy of a SC formulation of Entyvio as maintenance therapy in 216 adult patients with moderately to severely active UC who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous therapy at weeks 0 and 2.1<\/sup> The primary endpoint was clinical remission at week 52, which was defined as a total Mayo score of \u22642 and no subscore >1.1<\/sup><\/p>\n

\nTakeda expects a decision from the FDA by the end of 2023.<\/p>\n\n\n
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\n*Clinical response is defined as a reduction in complete Mayo score of \u22653 points and \u226530% from baseline (week 0) with an accompanying decrease in rectal bleeding subscore of \u22651 point or absolute rectal bleeding subscore of \u22641 point.1<\/sup><\/p>\n<\/td>\n<\/tr>\n<\/table>\n

About Entyvio\u00ae<\/sup> (vedolizumab)<\/b><\/p>\n

\nVedolizumab is a biologic therapy and is approved in intravenous (IV) and subcutaneous (SC) formulations (approvals vary by market; vedolizumab is not currently approved in the SC formulation in the U.S.).2,3 <\/sup>Vedolizumab SC has been granted marketing authorization in the European Union and more than 50 countries. Vedolizumab IV has been granted marketing authorization in more than 70 countries, including the United States and European Union, with more than 1,000,000 patient years of exposure to date.4<\/sup> It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).5<\/sup> MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.6<\/sup> The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.5<\/sup> These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn\u2019s disease (CD).5,7,8<\/sup> By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.5<\/sup><\/p>\n

IMPORTANT SAFETY INFORMATION FOR ENTYVIO IV<\/b><\/p>\n