Approval of first-ever medicine for rare blood vessels diseases offers hope for Canadians

Already approved for Non-Hodgkin's Lymphoma and Rheumatoid Arthritis, Health Canada approves RITUXAN^® (rituximab) for severe forms of vasculitis

TORONTO, Jan. 25, 2012 /CNW/ - Imagine what it would be like to live with a rare, life-threatening disease. Imagine how worried you might feel, particularly when you realize that there is no treatment approved for your disorder. Canadian adults living with Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA), two severe, potentially life-threatening forms of vasculitis, now have a treatment option to help combat their disease.¹ Today, Roche announced that RITUXAN^® (rituximab), in combination with glucocorticoids, is the first medicine approved by Health Canada for adults with severely active GPA and MPA.

"Orphan diseases of this nature are extremely difficult for patients to accept and for physicians to treat.  They are not widely understood and treatment options are often quite limited and not optimal leaving patients and their families feeling alone and without hope," says Dr. Éric Rich, Rheumatologist, Director, Rheumatalogy Post-Graduate Training Program, University of Montreal. "New treatment approaches like RITUXAN provide therapeutic choices for physicians to use in fighting this disease and give patients a better chance for remission."

What are GPA & MPA?

GPA and MPA are two severe forms of ANCA-Associated Vasculitis (AAV) - or vasculitis in short - a rare and potentially life-threatening disease in which the body's own immune system attacks healthy tissues and cells causing inflammation of the blood vessels.¹ This inflammation deprives affected tissues and organs of blood supply resulting in tissue or organ damage, including the potential for kidney failure or lung damage.¹ Both GPA and MPA are considered orphan (rare) diseases; GPA, for example, affects about 1 in 20,000 to 1 in 30,000 people in Canada.² In contrast, 487 Canadians are diagnosed with a form of cancer every day.³ GPA and MPA are unique diseases that are expressed differently from person to person, presenting with a variety of symptoms that range in severity; some are specific to a particular organ and others, such as aches, pains and fatigue, are non-specific.¹ Both GPA and MPA have a five-month survival rate, if left untreated.⁴

Treatment for Vasculitis?

Previously, there were no Health Canada approved medications to treat GPA and MPA. The current standard of care for orphan diseases such as vasculitis was developed in the early 1970s and has been the only option for many years, focused primarily on reducing discomfort and preventing serious complications.^5,6 As a result, some people go into remission, but for others, the disease remains chronic with recurring relapses. In fact, up to 20 per cent of patients do not achieve remission with the standard of care, and up to 50 per cent of GPA patients relapse at three years following diagnosis.⁷

RITUXAN, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severely active GPA and MPA.⁸ RITUXAN helps stop the body's own immune system from attacking itself. It is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells.

"I was diagnosed with a rare form of vasculitis 20 years ago after I was experiencing trouble breathing, constant headaches and nosebleeds, and inflammation of my joints," explains Jacques Ducharme, a GPA patient. "Now the simple act of walking or moving causes me excruciating pain. People don't realize the physical and emotional challenges my family and I face day in and day out as a result of living with GPA. I have to rely heavily on my wife for constant support.  Some days I can accept what's happening to me, and other days it's more challenging. Having the first approved treatment option for my orphan disease gives me hope for remission."

RAVE - Rituxan Clinical Study

Health Canada's approval of RITUXAN, in combination with glucocorticoids, for the treatment of GPA and MPA is based on a National Institute of Allergies and Infectious Diseases-sponsored study known as RAVE (Rituxan in ANCA-Associated Vasculitis). The study showed that RITUXAN was as effective as cyclophosphamide (CYC), part of the current standard of care, in inducing disease remission at six months in patients with severe AAV (vasculitis), however, with fewer side effects. The study also examined patients who developed adverse events including deaths, development of certain forms of cancers, blood disorders, infections, cardiovascular events, hospitalizations and infusion reactions. In this trial, 33 per cent (n=32) of those taking CYC developed one of the adverse events versus 22 per cent (n=22) of those on RITUXAN.⁹ For vasculitis patients with few new treatment options, the results of the RAVE study suggested RITUXAN is a potential option for vasculitis, and specifically for GPA and MPA, severe forms of the disease.

In Canada, RITUXAN is also indicated for the treatment of RA and non-Hodgkin's Lymphoma in adult patients.⁸ Over 170,000 patients worldwide have been treated with RITUXAN to date.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.  Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

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References
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¹ Vasculitis Foundation of Canada.  http://www.vasculitis.ca/.  Accessed October 2011.
² Vasculitis Foundation of Canada.  Wegener's Granulomatosis.  http://www.vasculitis.ca/wergenersgranulomatosis/vasculitis-resources/wergeners-granulomatosis.html.  Accessed October 2011.
³ Canadian Cancer Society.  General Cancer Statistics at a Glance.  http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/general%20cancer%20stats.aspx.  Accessed October 2011.
⁴ Bosch X, Guilabert A, Espinosa G, Mirapeix E (2007). "Treatment of antineutrophil cytoplasmic antibody associated vasculitis: a systematic review". JAMA 298 (6): 655-69.
⁵ Katsiari, C., Sakkas, L.  Treatment of ANCA - Associated Vasculitis.  Advances in the Diagnosis and Treatment of Vasculitis.
⁶ Vasculitis Foundation of Canada.  Vasculitis Medications.  http://www.vasculitis.ca/vasculitismedications/informative/medications-that-may-treat-vasculitis.html.  Accessed October 2011.
⁷ Criteria of Eligibility for Rituximab.
⁸ Canadian RITUXAN Product Monograph, 2011.
⁹ Stone H. et al. Rituximab versus Cyclophosphamide for ANCA-Associated Vasculitis. The New England Journal of Medicine. 363;3. July 15, 2010.