Biologic treatment ENTYVIO™ (vedolizumab) approved by Health Canada to treat Crohn’s disease

OAKVILLE, Ontario – May 19, 2016 – Health Canada has approved the biologic treatment ENTYVIO™ (vedolizumab) to treat adults with moderate to severely active Crohn’s disease (CD), the most common form of inflammatory bowel diseasei, offering an important new option for patients who don’t respond to or have failed on other treatments.

CD is a lifelong condition affecting more than 129,000 people in Canada.i It can be very debilitating and significantly compromise quality of life. [ii] Canada has among the highest reported prevalence and incidence of inflammatory bowel disease (IBD) in the world, causing some to call it Canada’s “national disease.” [iii]

ENTYVIO™ was first approved by Health Canada last year for the treatment of ulcerative colitis (UC), the second most common form of inflammatory bowel disease. [i] ENTYVIO™ is the first and only gut-selective biologic therapy with no known systemic immunosuppressive effects and approved for use in adult CD patients who have had an inadequate response, loss of response 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.

ENTYVIO™ works by targeting the gut, directly reaching inflammation that causes symptoms of CD and UC. [iv] In clinical studies, ENTYVIO™ demonstrated statistically significant benefits versus placebo over a year-long trial in patients with CD who had failed previous treatments, including biologics (almost 50% had failed prior TNFα antagonist therapy and approximately 30% had failed two or more). After 52 weeks, of those on ENTYVIO™ 39% achieved clinical remission (vs. 22% on placebo, p=0.0007), 44% had enhanced clinical response (vs. 30% on placebo, p=0.0132) and 32% achieved corticosteroid-free remission (vs.16% on placebo, p=0.0154). [v]

“Crohn’s disease is a major health issue in Canada, with prevalence growing and available treatments not universally effective, or losing their effectiveness in patients over time, so the need for new treatment options is great,” said Dr. Remo Panaccione, Professor in the Department of Medicine at the University of Calgary and Director of the inflammatory bowel disease clinic. “We’ve already had excellent and positive experience using ENTYVIO™ to treat patients with ulcerative colitis, so we are very pleased to now have it available for our Crohn’s disease patients as well because it is a whole new type of therapy. It selectively targets the gut, meaning it is taking on the disease head-on with no known systemic immunosuppressive effects, potentially leaving less room for side effects.”

“Crohn’s disease has a huge impact on the lives of people living with this disease as well as their families because the symptoms can greatly impact their quality of life - at home, at work or at school - particularly when treatments don’t provide the needed relief,” said Mina Mawani, President and CEO, Crohn’s and Colitis Canada. “When there are no further drug treatments to try, often the only remaining option is surgery to remove parts of the bowel, which can have a major lifelong impact on health, lifestyle and emotional well-being. That’s why having new treatment options is so important and why we are excited that research has led to the introduction of new treatments because patients need more options. Furthermore, Crohn’s and Colitis Canada is advocating to ensure that patients have timely and equitable access or coverage for all newly approved treatments for IBD. It’s vital for patients to be able to try all possible treatments before having to accept the last resort of bowel surgery.”

“So many of the Canadians with Crohn’s disease are young adults, at a stage in life when they want to be busy and active in school, build their careers, or start families. To live life as they hope to, they need effective treatments to keep the debilitating symptoms of Crohn’s disease under control. The approval of ENTYVIO™ offers an important new option for individuals for whom other treatments are not effective,” said Gail Attara, Co-founder, President, and CEO, Gastrointestinal Society. “We are optimistic that government and private drug coverage programs will recognize the very real need for new options so Crohn’s disease patients in every part of Canada will have coverage for this new treatment as soon as possible. We will work with all levels of government to ensure that patients get the help they need when they need it.”

A Canadian research milestone

The latest Health Canada approval is another milestone for the Canadian medical research community because of the pivotal role played by Canadian researchers in the treatment’s early discovery and development. Researcher Dr. Andrew Lazarovits of London, Ontario, developed a first potential molecule for this type of therapy while working in Boston but passed away in 1999 at age 44. [vi]

His work was taken up by others, resulting in the development of vedolizumab and eventually international clinical trials financed by Takeda which were led by Dr. Brian Feagan, director of Robarts Clinical Trials at the Robarts Research Institute in London, Ontario. The treatment was first used on an ulcerative colitis patient at University Hospital in London[vii] and Dr. Feagan was the lead author of the publication of the trial results in The New England Journal of Medicine in 2013. [iv]

ENTYVIOTM dosing, efficacy and safety

ENTYVIO™ (vedolizumab) is 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 tumor necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids. [v]

The recommended dose regimen of ENTYVIO™ is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter. [v]

The safety and efficacy of ENTYVIO™ for the treatment of adult patients with moderately to severely active Crohn’s disease was demonstrated in GEMINI II, a randomized, double-blind, placebo-controlled trial. Patients enrolled in the trial had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or TNFα antagonists. TNFα antagonist failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant to a TNFα antagonist. Almost 50% of the overall population in GEMINI II CD Trial had failed prior TNFα antagonist therapy and approximately 30% had failed two or more prior TNFα antagonist therapies. After 52 weeks, of those on ENTYVIO™ 39% achieved clinical remission (vs. 22% on placebo, p=0.0007), 44% had enhanced clinical response (vs. 30% on placebo, p=0.0132) and 32% achieved corticosteroid-free remission (vs. 16% on placebo, p=0.0154). [v]

The ENTYVIO™ tolerability profile 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. [v]

YOURVANTAGE™ patient support program

Canadian patients prescribed ENTYVIO™ are enrolled in YOURVANTAGE™, a Takeda Canada Inc. patient support program by Takeda’s partner, Innomar Strategies. The program arranges convenient times and locations for patients to receive the treatment by intravenous infusion at one of the Innomar clinics across Canada. It also provides patients with information about their disease, the treatment and advice about securing insurance reimbursement. For more information, visit www.yourvantage.ca.

About Crohn’s disease

More than 129,000 Canadians are living with CD.i CD may involve inflammation in different parts of the gastrointestinal (GI) tract in different people; however, it most commonly affects the lower part of the small intestine (the ileum) where it joins the beginning of the colon. [ii] With CD, patches of inflammation are interspersed between healthy portions of the GI tract, and the inflammation can penetrate the entire thickness of the bowel wall. [viii] Symptoms of CD often include abdominal pain, cramping, diarrhea, nausea, vomiting, weight loss and lack of energy. [viii] The most common complication of CD is blockage of the intestine due to swelling and the formation of scar tissue which may require surgery if the obstruction is severe and does not respond to medical treatment.ii The exact cause for CD is not entirely understood, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors may play a role. [ix] More than 5,700 cases of CD are diagnosed each year. [i]

About Takeda Canada

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and marketing organization of Takeda Pharmaceutical Company Limited, Osaka, Japan. The company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include gastroenterology, oncology, metabolic diseases, central nervous system diseases, general medicine, and vaccines.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through strategic acquisitions, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda Canada is available through its website: www.takedacanada.com.

[i] Crohn’s and Colitis Canada, Fast Facts: Impact of IBD in Canada 2012, accessed at: http://www.isupportibd.ca/pdf/ccfc.ca-impact-report-fast-facts.pdf

[ii] Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, p.17; p. 21 accessed at: http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf

[iii] Media Planet, Digestive Wellness Supplement, Tackling the burden of ulcerative colitis, March 2015, accessed at: http://www.personalhealthnews.ca/prevention-and-treatment/tackling-the-burden-of-ulcerative-colitis

[iv] Feagan BG et al, Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis, N Engl J Med 2013; 369:699-710, August 22, 2013, page 700, accessed at: http://www.nejm.org/doi/full/10.1056/NEJMoa1215734

[v] Takeda Canada Inc., ENTYVIO™ (vedolizumab) Product Monograph, March 22, 2016

[vi] Feagan BG et al, Treatment of Active Crohn's Disease With MLN0002, a Humanized Antibody to the α4β7 Integrin, Clinical Gastroenterology and Hepatology, 2008; 6:12, 1370–1377 accessed at: http://www.cghjournal.org/article/S1542-3565%2808%2900617-4/abstract and Sher J, Approval being sought for new treatment for Crohn’s and colitis, The London Free Press, Aug. 21, 2013, accessed at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

[vii] Sher J, Approval being sought for new treatment for Crohn’s and colitis, The London Free Press, Aug. 21, 2013, accessed at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

[viii] Crohn’s and Colitis Canada, What are Crohn’s and colitis?, accessed at: http://www.crohnsandcolitis.ca/site/c.dtJRL9NUJmL4H/b.9012445/k.8EB2/What_are_Crohns_and_colitis.htm

[ix] Crohn’s and Colitis Foundation of America, The Facts about Inflammatory Bowel Disease, page 5, at: http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf