TORONTO, Ontario, April 9, 2020 – Takeda Canada Inc. is pleased to announce that ENTYVIO® (vedolizumab) has been approved as a self-injectable subcutaneous format for at-home maintenance treatment of adult patients 18 years or older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a tumor necrosis factor-alpha (TNFα) antagonist.
The approval of a self-injectable formulation of ENTYVIO® is based on the VISIBLE 1 randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of subcutaneous ENTYVIO® as maintenance therapy for adult patients with moderately to severely active ulcerative colitisi.
“The approval of a formulation of vedolizumab for ulcerative colitis that can be self-administered is welcome news for our patients who live with this lifelong condition,” said Dr John Marshall, Professor of Medicine, Director, Division of Gastroenterology, McMaster University. “Having the choice of a self-injectable format will give patients more control in the management of their disease. I look forward to a self-injectable formulation being made available in Canada.”
Canada has among the highest rates of ulcerative colitis in the world. It is one of two main forms of inflammatory bowel disease (IBD), affecting approximately 120,000 Canadian and impacting all aspects of quality of life for those who live with it ii.
“As a company that has been innovating in this disease area for a number of years, we understand the burden and toll IBD has on Canadians. Takeda is a dedicated, long-term partner to the GI and IBD community and introducing another option will help meet individual needs and patient preferences, said Gamze Yüceland, General Manager, Takeda Canada.
ENTYVIO® (vedolizumab) for intravenous infusion is approved by Health Canada for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonistii ENTYVIO® for intravenous infusion is also indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumour necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroidsi.
The recommended dose regimen of intravenous ENTYVIO® is 300 mg administered at zero, two and six weeks and then every eight weeks thereafteri. After completion of at least two intravenous doses of ENTYVIO®, ulcerative colitis patients showing clinical response may switch to subcutaneous maintenance dosingi. The recommended dose regimen of subcutaneous ENTYVIO® as a maintenance treatment, following at least two intravenous infusions, is 108 mg administered by subcutaneous injection once every two weeksi. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every two weeks thereafteri.
The tolerability profile of intravenous ENTYVIO® was demonstrated in the 52-week GEMINI trials, with a low rate of discontinuations due to adverse events: 9% for those on ENTYVIO® vs.10% for those on placeboi. The efficacy and safety of subcutaneous ENTYVIO® for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis was demonstrated in the VISIBLE UC 1 trial, a randomized, double-blind, placebo-controlled study evaluating efficacy endpoints at Week 52i. No clinically relevant differences in the overall safety profile and adverse events were observed in patients who received subcutaneous ENTYVIO® compared to the safety profile observed in clinical studies with intravenous vedolizumab with the exception of injection site reactions with subcutaneous administration onlyi. In pooled safety analysis in ulcerative colitis patients receiving subcutaneous ENTYVIO® injection site reactions were reported in 7.6% of patientsi.
About Takeda Canada Inc.
Takeda Canada Inc. is the Canadian marketing and sales organization of Takeda Pharmaceutical Company Limited, headquartered in Japan. Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
Additional information about Takeda Canada is available at www.takeda.com/en-ca.
Amanda Jacobs, firstname.lastname@example.org, +1 647 798 2231
ENTYVIO® is a registered trademark of Millennium Pharmaceuticals, Inc. and used under licence by Takeda Canada Inc
[i] ENTYVIO® (vedolizumab) Product Monograph. April 7, 2020
[ii] Crohn’s and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease in Canada Report p12, 110. Available at: https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf