GASTRO OFFICE BREAKS NEW GROUND FOR PATIENTS BY BECOMING THE FIRST PRACTICE IN OHIO TO USE CELLVIZIO TO IMPROVE THE DIAGNOSIS AND TREATMENT OF BARRETT’S ESOPHAGUS
to remove precancerous tissue in the hopes of preventing further spread of the disease.
Cellvizio, from Mauna Kea Technologies, is the only device that uses confocal laser endomicroscopy (CLE) to give physicians the power to see in vivo real-time cellular changes and responses to therapies
Gastro Office serves patients in the greater Columbus, OH area, treating conditions that affect the health of the digestive tract, including the esophagus, stomach, small and large intestines, pancreas, gallbladder, bile ducts, and liver.
Boston (May 31, 2023) – Patients in Ohio who suffer from persistent heartburn, reflux, and upper gastrointestinal pain and discomfort now have access to advanced imaging technology that can deliver a more accurate diagnosis in less time, thanks to Gastro Office. Hilliard Endo Center in Hilliard, OH is a surgery center affiliated with Gastro Office, which became the first center in Ohio to use Cellvizio® for these health conditions.
To learn more about their services, visit
GastroOffice.com
or call 614-385-5900
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point- in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients.
TAKEDA ANNOUNCES FDA ACCEPTANCE OF BLA RESUBMISSION FOR INVESTIGATIONAL SUBCUTANEOUS ADMINISTRATION OF ENTYVIO® (VEDOLIZUMAB) FOR MAINTENANCE THERAPY IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS
OSAKA, Japan and CAMBRIDGE, Massachusetts, April 27, 2023 – Takeda (TSE:4502/NYSE:TAK) (“Takeda”) 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® (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).
“Takeda 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 – whichever suits their medical and personal needs. This resubmission is a major step forward in delivering on that commitment,” said
Vijay Yajnik, M.D., Ph.D., vice president,head of U.S. Medical for Gastroenterology, Takeda. “We 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.”
alpha4beta7 integrin is expressed on a subset of circulating white blood cells.5 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).5,7,8 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.5
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).9 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract.10,11 UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus.12,13 CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine.12,13 UC can present with symptoms of abdominal discomfort or loose bowel movements, including blood.12,14 CD can present with symptoms of abdominal pain, diarrhea, and weight loss.10 The cause of UC or CD is not fully understood; however, research suggests that an interplay between environmental factors, genetics, and intestinal microbiota may contribute to the development of UC or CD.12,15,16
Takeda expects a decision from the FDA by the end of 2023.
with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point.1
About Entyvio® (vedolizumab)
Vedolizumab 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 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 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 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.6 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.5 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).5,7,8 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.5
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).9 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract.10,11 UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus.12,13 CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine.12,13 UC can present with symptoms of abdominal discomfort or loose bowel movements, including blood.12,14 CD can present with symptoms of abdominal pain, diarrhea, and weight loss.10 The cause of UC or CD is not fully understood; however, research suggests that an interplay between environmental factors, genetics, and intestinal microbiota may contribute to the development of UC or CD.12,15,16
REFERENCES
Sandborn WJ, Baert F, Danese S, et al.Gastroenterology. 2020;158(3):562-572.
Entyvio Prescribing Information. Available at: https://general.take- dapharm.com/ENTYVIOPI.Last updated: June 2022. Last accessed: January 2023.
Entyvio Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/ entyvio-epar-product-information_en.pdf. Last updated: October 2022. Last accessed: February 2023.
Takeda data on file (VV-SUP-91507): Vedolizumab Patient Exposure from Marketing Experience. 2021.
Soler D, Chapman T, Yang LL, et al. J Pharmacol Exp Ther. 2009;330:864-875.
Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151:97-110.
Eksteen B, Liaskou E, Adams DH. Inflamm Bowel Dis. 2008;14:1298-1312.
Wyant T, Fedyk E, Abhyankar B. J Crohns Colitis. 2016;10:1437-1444. Baumgart DC, Carding SR. Lancet. 2007;369:1627-1640.
Baumgart DC, Sandborn WJ. Lancet. 2012;380:1590-1605.
Torres J, Billioud V, Sachar DB, et al. Inflamm Bowel Dis. 2012;18:1356-1363.
Ordas I, Eckmann L, Talamini M, et al. Lancet. 2012;380:1606-1619. Feuerstein JD, Cheifetz AS. Mayo Clin Proc. 2017;92:1088-1103. Sands BE. Gastroenterology. 2004;126:1518-1532.
Kobayashi T, Siegmund B, Le Berre C, et al. Nat Rev Dis Primers. 2020;6(74).
Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Lancet. 2017; 389(10080):1741-1755.