COSENTYX® - first Interleukin-17A inhibitor for psoriatic arthritis and ankylosing spondylitis approved by Health Canada(1)

• In psoriatic arthritis (PsA) and ankylosing spondylitis (AS), the inhibition of Interleukin-17A (IL-17A) leads to less tender and swollen joints and better joint function^2-4
  
  
• The approval of Cosentyx^® marks the only new targeted therapy available in AS in Canada in more than a decade⁵
  
  
• Cosentyx^® approvals in PsA and AS follow the 2015 indication for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults⁶

DORVAL, QC, April 27, 2016 /CNW/ - Cosentyx^® (secukinumab) has been approved by Health Canada in two new indications: for the treatment of adult patients with active psoriatic arthritis (PsA) when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate; and for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. In PsA, Cosentyx^® can be used alone or in combination with methotrexate¹.

New medicines for people living with PsA and AS have been urgently needed. When not managed effectively, PsA and AS can cause painful, long-term damage to the joints and spine^7,8. Many patients do not receive an adequate response from conventional treatments such as DMARDs and non-steroidal anti-inflammatories^9,10. Furthermore, research shows up to 40% of patients do not respond sufficiently to anti-tumor necrosis factor (anti-TNF) therapies and 45% of PsA patients are unsatisfied with their treatments^9,10. Cosentyx^® will provide a clinically-proven option for the unmet need in the treatment of newly diagnosed Canadians, as well as those already receiving standard therapies for PsA and AS⁹.

Today's announcement follows the 2015 Health Canada approval of Cosentyx^® for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy ⁶. Of the approximately 1 million Canadians living with psoriasis, up to 30% will be diagnosed with psoriatic arthritis^11-12 and one in four may have undiagnosed PsA¹³. Ankylosing spondylitis occurs in up to 1% of the general population and typically affects young men and women aged 25 or older^14-15. Certain genetic factors increase a person's risk of developing AS by more than 50%¹⁶. 

"As someone directly affected by psoriasis, I know firsthand the daily challenges Canadians endure living with a chronic condition.  Your disease impacts every aspect of your life.  At times, you feel like your disease controls your life," said Andrew Gosse, Founder and President of the Canadian Psoriasis Network (CPN). "I also understand the issues that could come about for me and other Canadians in my circumstance when our psoriasis evolves into psoriatic arthritis if not managed effectively. That's why it is so encouraging to see the approval of new, clinically proven and extensively researched treatment options for autoimmune conditions."

"The popular perception of arthritis is that it's an old person's disease, but AS is a young person's disease. My AS symptoms began when I was 33 and the impact on my life was almost immediate. It took another 10 years until I was diagnosed and could begin treatments" said Michael Mallinson, AS patient and President of the Canadian Spondylitis Association (CSA). "Today's announcement underscores the importance of continued research into autoimmune conditions and the need to provide the best possible care and treatment options for those managing their conditions so patients can lead active and fulfilling lives."

About Cosentyx^® (secukinumab) and interleukin-17A (IL-17A)
Secukinumab is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A)^17-19. IL-17A is one of the many proteins in the body called cytokines that help protect the body against infections¹⁹. It has been identified as playing a key role in a number of immune-mediated diseases such as psoriasis, PsA and AS²⁰. In the Phase III clinical program, Cosentyx^® demonstrated a favorable safety profile, with similar incidence and severity of adverse events between Cosentyx^® treatment arms²¹. In 2015, Cosentyx^® was approved by Health Canada for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy⁶. Most recently, it received approval for the treatment of adult patients with active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Cosentyx^® can be used alone or in combination with methotrexate. Cosentyx^® also received approval for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy¹.

About psoriatic arthritis (PsA)
Psoriatic arthritis (PsA) is part of a family of life-long inflammatory diseases that also include ankylosing spondylitis (AS). It is also closely associated with psoriasis. Up to 30% of patients with psoriasis have PsA²² and as many as one in four people with psoriasis may have undiagnosed PsA¹³. It is a debilitating, chronic disease linked with significant disability, poor quality of life and reduced life expectancy²³. Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful swelling of the tendons (tendonitis), and irreversible joint damage²⁴. Up to 40% of those affected can suffer from joint destruction and permanent physical deformity²⁵.

About ankylosing spondylitis (AS)                                                   
Ankylosing spondylitis (AS) is a common type of spondyloarthritis (SpA), a family of long-term diseases of joints (inflammatory disease), which also includes psoriatic arthritis (PsA)²⁶. AS is a painful, progressively debilitating condition caused by inflammation of the spine and can have serious consequences, including irreversible spinal damage. People living with AS can become progressively disabled and unable to work, which may add to their reduced quality of life^26-28. Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life^26,28-29. AS occurs in up to 1% of the general population and typically affects young men and women aged 25 or older^14-15. Certain genetic factors increase a person's risk of developing AS by more than 50%¹⁶.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Pharmaceuticals Canada Inc. employs more than 700 people in Canada. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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Cosentyx is a registered trademark.

References

1. Cosentyx^®  Product Monograph. Novartis Pharmaceuticals Inc. April 20, 2016.
2. Mease PJ et al. Secukinumab, a human anti-interleukin17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386(9999):1137-1146.
3. Mease PJ et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015;373(14):1329-39.
4. Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015;373:2534-48.
5. Doc Guide. Health Canada Approves Enbrel (Etanercept) for Psoriasis treatment. 2006. Accessed April 22, 2016.
6. Cosentyx^® Product Monograph, Novartis Pharmaceuticals Canada Inc., February 27, 2015.
7. The Arthritis Society. Ankylosing Spondylitis: Know your Options. Available at:  http://arthritis.ca/getmedia/cf8729ed-4482-48af-9170-5cf5f8475f63/Ankylosing-Spondylitis.pdf?ext=.pdf. Accessed: April 20, 2016.
8. The Arthritis Society. Psoriatic Arthritis: Know your Options. Available at:  http://arthritis.ca/getmedia/76b245ce-5287-4bb9-8c1e-c97f14154bd3/Psoriatic-Arthritis.pdf?ext=.pdf. Accessed: April 20, 2016.
9. Armstrong A et al. JAMA Dermatol. 2013;149(10):1180-1185
10. Dougados M, Baeten D. Spondyloarthritis. Lancet. 211;377;127-37.
11. The Arthritis Society (Canada) website. Psoriatic Arthritis. Accessed April 2016.
12. Canadian Association of Psoriasis Patients website. Living with Psoriasis. Accessed April 2016.
13. National Psoriasis Foundation. Press release: Nearly one in four people with psoriasis may have undiagnosed psoriatic arthritis according to a recent study from the National Psoriasis Foundation (link is external). Last accessed October 2015.
14. Braun J, Bollow M, Remlinger G, et al. Prevalence of spondylarthropathies in HLA-B27 positive and negative blood donors. Arthritis Rheum. 1998;41(1):58-67.
15. Feldtkeller E, Khan M, Van Der Heijde D, et al. Age at disease onset and diagnosis delay in HLA-B27 negative vs. Positive patients with ankylosing spondylitis. Rheumatology International. 2003;23(2):61-66.
16. Brown MA. Progress in studies of the genetics of ankylosing spondylitis. Arthritis Res Ther. 2009;11:254.
17. Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009;9(8):556-67.
18. Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
19. Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-21.
20. Kopf M. Et all. Averting inflammation by targeting the cytokine environment. Drug Discovery. 2010. 703-718.
21. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in Plaque Psoriasis – Results of Two Phase Three Trials. N Engl J Med. 2014; 371(4):326-338.
22. Zachariae H. Prevalence of joint disease in patients with psoriasis: implications for therapy. Am J Clin Dermatol. 2003; 4:441–7.
23. Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
24. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014; 74:423–441.
25. Anwar AH, Diamond H. Psoriatic arthritis: practice essentials, background, pathophysiology and etiology. Medscape reference website (link is external). Last accessed October 2015.
26. American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy) (link is external)". Accessed December 2013.
27. Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.
28. Barkham N, Kong KO, & Tennant A. The unmet need for anti-tumour necrosis factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology. 2005;44:1277-81.
29. Lories R. The balance of tissue repair and remodeling in chronic arthritis. Nat Rev Rheumatol. 2011;7:700- 07.

SOURCE Novartis Pharmaceuticals Canada Inc.

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