Novartis Pharmaceuticals Canada Inc. receives Health Canada approval for ILARIS* in active Systemic Juvenile Idiopathic Arthritis, a serious form of rare childhood arthritis

ILARIS* is the first interleukin-1 beta (IL-1 beta) inhibitor for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) and is the only monthly subcutaneous treatment approved specifically for SJIA [1]

DORVAL, QC, Dec. 17, 2013 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Health Canada has approved the use of ILARIS^* (canakinumab) in the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older. SJIA is a rare and disabling form of childhood arthritis with limited treatment options [2]. The condition is characterized by spiking fever, rash and arthritis that can affect children as young as two years old and can continue into adulthood [2],[3].

"Arthritis can affect anyone, including babies and children. This approval is welcome news for Canadian families with children living with SJIA, a rare form of juvenile arthritis, offering them a new treatment option," said Joanne Simons, Chief Mission Officer, The Arthritis Society.

Health Canada approved ILARIS* based on data from the Novartis Phase III trials published in the New England Journal of Medicine in December 2012. Study 1 showed that 84% of patients treated with one subcutaneous dose of ILARIS^* achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15 [1]. In the open-label part of Study 2, 92 of 128 patients attempted "corticosteroid tapering."

Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids [1]. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the ILARIS^* group as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75) [1].

"The Health Canada approval of ILARIS* provides patients living with SJIA with a new treatment option. This represents another significant milestone in the development of ILARIS^* as a therapy for patients with rare, auto-inflammatory diseases, where interleukin-1 beta plays a key role." said Tina Cantrill, Vice President of Integrated Hospital Care & Critical Care at Novartis.

As many as 24,000 Canadian children aged 18 and under live with a form of arthritis, or more than 3 out of every 1,000 kids [4]. The systemic JIA variant is significantly rarer. Although the disease can be life-threatening, treatment options are limited. Corticosteroids are often used to treat symptoms and pain despite their long-term use being associated with potentially serious adverse effects, including Cushing syndrome, growth suppression and osteoporosis [1].

"Systemic Juvenile Idiopathic Arthritis (SJIA) is both a rare and potentially severe, debilitating disease. Unlike other forms of juvenile arthritis, SJIA may affect a child's entire body. The persistent inflammation, fevers, rash, and joint pain that accompany the disease often mean that children are unable to enjoy many of the everyday life experiences that are fundamental to childhood. The disease can also be complicated by growth failure, osteoporosis and deformities. Because of the potentially severe nature of SJIA, early diagnosis and treatment is paramount," said Dr Rayfel Schneider, MBBCh, FRCPC, Professor and Associate Chair Staff, Division of Rheumatology, Department of Paediatrics at the University of Toronto and Hospital for Sick Children.

"Of the approximately 7,000 rare diseases, fewer than 400 have effective treatments.  We are very excited that Canadian children with SJIA now have access to a new treatment option." said Durhane Wong-Rieger, President and CEO of the Canadian Organization for Rare Disorders.

About ILARIS*
ILARIS^* is a selective, fully human, monoclonal antibody that inhibits IL-1 beta, which is an important part of the body's immune system defenses [1]. Excessive production of IL-1 beta plays a prominent role in certain inflammatory diseases [5]. ILARIS* works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation [1].

ILARIS* is now approved for the treatment of SJIA in Canada [1]. In this indication, it has been shown to provide rapid and sustained improvement of acute disease by controlling both systemic and joint inflammation, allow successful tapering and elimination of steroids in most patients and offer the opportunity to achieve and maintain inactive disease over a sustained period of time [1],[6].  ILARIS* is also approved in Canada for the treatment of Cyropyrin Associated Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with debilitating symptoms [1].

About Novartis
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. In 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG, which 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, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

*ILARIS is a registered trademark.

References:
[1] ILARIS^* Product Monograph. Novartis Pharmaceuticals Canada Inc. December, 2013.
[2] Woo P. Systemic juvenile idiopathic arthritis: diagnosis, management, and outcome. Nat Clin Pract Rheumatol 2006; 2(1):28-34.
[3] Ramanan AV, Grom AA. Does systemic-onset juvenile idiopathic arthritis belong under juvenile idiopathic arthritis? Rheumatology (Oxford) 2005; 44(11):1350-3.
[4] The Arthritis Society http://arthritis.ca/page.aspx?pid=7224. September 26 2013.
[5] Martinon F, Petrilli V. Gout-associated uric acid crystals activate the NALP3 inflammasome. Nature 2006; 440(9): 237-241.
[6] Ruperto N, et al. N Engl J Med. 2012; 367:2396-406

SOURCE: Novartis Pharmaceuticals Canada Inc.

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