Ready-to-use self-injectable formulation of ENTYVIO® (vedolizumab) now available for Canadians for the maintenance treatment of moderately to severely active Crohn's disease and ulcerative colitis

• Latest approval by Health Canada provides flexibility to choose the route of administration for ENTYVIO^®, the first maintenance therapy for the treatment of both Crohn's disease and ulcerative colitis approved in both IV and subcutaneous formulations
  
  
• New pre-filled syringe or pen options provide patients the choice of self-administration at home

TORONTO, Jan. 19, 2021 /CNW/ - Takeda Canada Inc. is pleased to announce that Canadians with Crohn's disease (CD) now have an additional treatment option available to them with the approval by Health Canada of ENTYVIO^® (vedolizumab) in a new ready-to-use self-injectable subcutaneous format for at-home maintenance treatment of the condition. The self-injectable format was also recently approved by Health Canada for the maintenance treatment of ulcerative colitisⁱ (UC), which together with CD comprise the two main forms of inflammatory bowel disease (IBD)ⁱⁱ.

For decades, the incidence of IBD in Canada has been increasing and today Canada has among the highest incidence and prevalence in the worldⁱⁱⁱ. Having ENTYVIO^® available in Canada to treat CD and UC in both subcutaneous and intravenous formulations gives Canadians living with either form of IBD the flexibility to choose the route of administration that best meets their needs.

"Having a formulation of vedolizumab that can be self-administered is an important new delivery method for IBD patients with Crohn's disease or ulcerative colitis. These diseases are lifelong conditions so giving patients choices is helpful when it comes to managing this disease," said Dr. Brian Bressler, Director of the Advanced IBD Training Program and Clinical Associate Professor of Medicine at the University of British Columbia. "Some patients prefer this option because it gives them greater control over when and where they receive their treatment. The availability of this at-home format could not have come at a better time, particularly in today's environment." 

ENTYVIO^® is indicated for use in adult patients 18 years or older with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumor necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids and for use in adult patients with moderately to severely active UC who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonistⁱ.

IBD affects approximately 270,000 Canadians and impacts all aspects of quality of life for those who live with it^iv. While IBD can be diagnosed at any age, the age groups that are most likely to receive a diagnosis are adolescents and young adults from 20 to 30 years of age^iv.

"People living with chronic conditions like Crohn's disease or ulcerative colitis face many challenges in managing their disease. Having options in treatment approaches gives people more freedom in making choices that best meet their needs," says Susan Cowan, Chief Executive Officer of Crohn's and Colitis Canada. "This new route of administration for vedolizumab for Crohn's disease as well as the self-injectable format approved for ulcerative colitis is well-received by the IBD community. The ability to self-administer medication in a home setting is especially relevant during the COVID-19 pandemic for people looking to reduce time spent outside the home." 

Takeda is committed to ongoing investment in research and development and driven to continually seek ways to improve quality of life for patients with IBD through innovative solutions.

"Takeda is committed to continued innovation in IBD to bring novel solutions to meet the diverse needs of the patients we serve. We put the health and wellbeing of patients first and support them through different programs, ongoing research and by advancing science to give patients options that reflect their lifestyle. The availability of this new formulation of ENTYVIO^® marks an important milestone in our continued commitment," said Dr. Jefferson Tea, Vice-President Medical & Scientific Affairs, Takeda Canada. 

About ENTYVIO^®i
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 antagonist. 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 corticosteroids.

The recommended dose regimen of intravenous ENTYVIO^® is 300 mg administered at zero, two and six weeks and then every eight weeks thereafter. After completion of at least two intravenous doses of ENTYVIO^®, ulcerative colitis or Crohn's disease patients showing clinical response may switch to subcutaneous maintenance dosing. 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 weeks. The first subcutaneous dose should be administered in place of the next scheduled intravenous dose and every two weeks thereafter.

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 placebo. The efficacy and safety of subcutaneous ENTYVIO^® for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn's disease was demonstrated in the VISIBLE UC 1 and VISIBLE 2 CD trials, randomized, double-blind, placebo-controlled studies evaluating efficacy endpoints at Week 52. The safety of subcutaneous ENTYVIO^® for maintenance treatment of ulcerative colitis or Crohn's disease from both controlled and open-label studies was consistent with the known safety profile of intravenous ENTYVIO^® except for injection site reactions. In patients receiving subcutaneous ENTYVIO^® (N=811), injection site reactions were reported in 5.1% of patients. Hypersensitivity reactions considered treatment-related by the investigators were reported in 3.5% of patients.

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. 

ENTYVIO^® is a registered trademark of Millennium Pharmaceuticals, Inc. and used under licence by Takeda Canada Inc.

References
______________________________
ⁱ Takeda Canada Inc., ENTYVIO^® (vedolizumab) Product Monograph, November 19, 2020, p. 4. Available at: https://www.takeda.com/4ab3be/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/entyvio/entyvio-pm-en.pdf

ⁱⁱ Crohn's and Colitis Canada, About Crohn's and Colitis. Available at: http://www.crohnsandcolitis.ca/About-Crohn-s-Colitis/What-are-Crohns-and-Colitis

ⁱⁱⁱ Gilaad G Kaplan, Charles N Bernstein, MD, Stephanie Coward, et al. The Impact of Inflammatory Bowel Disease in Canada 2018: Epidemiology, Journal of the Canadian Association of Gastroenterology, Volume 2, Issue Supplement_1, February 2019, Pages S6–S16,.Available at: https://doi.org/10.1093/jcag/gwy054

^iv Crohn's and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease in Canada Report. Available at: https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf

SOURCE Takeda Canada Inc.

Media Contact: Amanda Jacobs, [email protected], [phone]