Novartis announces that Xolair® is approved in Canada as a licensed therapy for chronic idiopathic urticaria (CIU) patients unresponsive to antihistamines

• Xolair^® (omalizumab) is approved by Health Canada as a treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1-antihistamine treatment.¹
• CIU is an unpredictable skin disease characterized by the presence of a debilitating form of chronic itch, hives with or without angioedema (deep swelling in the tissue of the skin), for more than six weeks, that can negatively impact a patient's quality of life^2-6.
• Women suffer from urticaria nearly twice as much as men do and that the peak age of incidence is between 20 and 40 years⁵.
• Up to 50% of CIU patients will experience inadequate response to licensed doses of H1-antihistamines⁵

DORVAL, QC, Aug. 28, 2014 /CNW/ - Novartis Pharmaceuticals Canada Inc. announced today that Health Canada has approved the use of Xolair^® (omalizumab) as a treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1-antihistamine treatment. The approved doses are 150 mg and 300 mg by subcutaneous injection every four weeks.

"Chronic idiopathic urticaria, commonly known as hives or chronic spontaneous urticaria (CSU) occurs without known cause or warning. This debilitating immunologic skin disease is largely unknown by Canadians and healthcare professionals which makes it difficult to diagnose and challenging to treat. CIU or CSU significantly interferes with every aspect of a person's life including the way they sleep, eat, work, and interact with others. Increasing awareness of complexities associated with skin autoimmune diseases like CIU or CSU and their daily impact with a poor overall quality of life is very important,"‎ said Dr. Gordon Sussman, MD, FRCPC, Allergist and Clinical Immunologist.

Health Canada approved Xolair^® based on positive and consistent results from two Phase III studies (ASTERIA I, ASTERIA II) that involved nearly 650 patients with CIU not adequately controlled with antihistamines therapy^{7, 8}. Xolair^® 150 mg and 300 mg met the primary endpoint across these studies demonstrating significant improvement in itch intensity (seen as early as one week) comparing to placebo. In many cases patients achieved complete symptoms control (UAS7=0)^{7, 8}.

CIU is defined as the presence of spontaneously occurring hives and/or angioedema with variable degrees of pruritus (itch) for a period longer than 6 weeks¹⁰. Although 6 weeks' duration is the requirement for chronicity, CIU can persist for years: average duration of CIU is between 1 to 5 years⁵, however, up to 14% of the patients can have CIU for more than 5 years⁵. The chronicity aspect of CIU will significantly impact a person's life as it can potentially cause experiencing major disability, emotional distress and decreased productivity¹⁰.

"CIU is a chronic and truly debilitating skin disease.  It is important to underline the outstanding commitment of allergists, dermatologists and immunologists to find a solution to the unmet needs in CIU disease management," said Tim Maloney, President of Novartis Pharmaceuticals Canada Inc.‎ "Novartis is pleased to offer a therapeutic option for Canadians who remain symptomatic despite the use of antihistamines. With this new therapeutic option from our specialty ‎portfolio, our aim is to provide Canadians living with skin diseases treatment options for improved care." 

About the Pivotal Phase III Xolair^® CIU Studies
Phase III studies, ASTERIA I and ASTERIA II, evaluated the efficacy and safety of Xolair^® relative to placebo in nearly 650 CIU patients not adequately controlled with antihistamines therapy ^7,8. In these two Phase III studies, a significant proportion of patients became either completely free of itch and hives (UAS7=0) (15% and 22% at 150 mg respectively and 36% and 44% at 300 mg respectively) or were well controlled (UAS7≤6) (40% and 43% at 150 mg respectively and 52% and 66% at 300 mg respectively)^7,8.

ASTERIA I and ASTERIA II were international, multi-center, double-blind randomized studies that evaluated the efficacy and safety of Xolair^® compared to placebo. The studies enrolled 318 patients and 323 patients respectively, aged between 12 and 75 with moderate to severe CIU despite standard-of-care therapy, consisting of concomitant H1-antihistamine therapy (at approved doses)^7,8. Patients were randomized to Xolair^® 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks^7,8. ASTERIA I had a 24-week treatment period, with a 16-week follow-up and ASTERIA II had a 12-week treatment period, with a 16-week follow-up period^7,8. In the ASTERIA I study, Xolair^®-treated patients experienced a rapid reduction in itch and hives as early as Week 1, with therapeutic benefit sustained over 24 weeks of active treatment⁷.In the ASTERIA II study, 22% and 44% of patients receiving Xolair^® 150 mg and 300 mg, respectively, were itch-and hive-free after 12 weeks of treatment⁸.

In these Phase III studies, the incidence and severity of adverse events (AEs) was similar between Xolair^® and placebo groups^7,8. The most commonly reported adverse reactions observed were headache and nasopharyngitis.

About CIU
CIU, also referred in some studies as chronic spontaneous urticaria (CSU), is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin that spontaneously present and reoccur for more than six weeks^2-4.

At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population⁵, and up to two thirds of these patients have CIU^5,12. Up to 40% of CIU patients also experience concomitant angioedema, a swelling in the deep layers of the skin¹. The majority of studies clearly show that women suffer from urticaria nearly twice as much as men do and that the peak incidence is reported between 20 and 40 years which means that patients are affected in the prime of both their work and family lives⁵.

CIU is described by patients as a very distressing and unpredictable disease. Patients experience occupational disabilities, depression, lack of sleep, fatigue, pain, and social isolation, which impart a significant negative impact on their daily functioning, thus drastically lowering their quality of life^5,9. Disfigurement and discomfort associated with this disorder can often pose long-term hardship for patients and their families¹¹. CIU also results in a considerable economic burden. Although most patients with CIU are relatively young and otherwise healthy, their health care costs can be substantial. Medication and outpatient visits (direct costs), and lost productivity due to absence from work (indirect costs) are major cost drivers for CIU^13,14.

About Xolair^® (omalizumab)
Xolair^® (omalizumab) binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of Xolair^® result in an improvement of CIU symptoms is unknown¹. Research is ongoing to understand the mechanism of action of Xolair^® in CIU, which could lead to a deeper understanding of how the disease develops⁶. In Canada, Xolair^® (omalizumab) is also indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma¹ and has been in use since 2005.

About Novartis in specialty dermatology
Novartis is committed to developing specialty dermatology therapies, where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes Xolair^® (omalizumab) for the treatment of refractory chronic idiopathic urticaria (CIU), investigational secukinumab (AIN457) in psoriasis and investigational sonidegib (LDE225) for Basal cell carcinoma (BCC), a skin cancer. There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio.

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. In 2013, 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.

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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

^®Xolair is a registered trademark of Novartis Pharmaceuticals Canada Inc.

References

1.	Xolair^® Product Monograph, Novartis Pharmaceuticals Canada Inc.
2.	Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM. 2013; DOI: 10.1056/NEJMoa1215372.
3.	Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives)." http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed November 14, 2012.
4.	American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed November 14, 2012.
5.	Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011; 66: 317–330.
6.	Sánchez-Borges M, Asero R, Ansotegui IJ, et al. Diagnosis and treatment of urticaria and angioedema: a worldwide perspective (position paper). World Allergy Organization Journal. 2012; 5:125–147.
7.	Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and Safety of Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain Symptomatic on H1-Antihistamines: A Randomized, Placebo-Controlled Study. J Invest Dermatol. 2014 Jul 21. doi: 10.1038/jid.2014.306. [Epub ahead of print].
8.	Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM. 2013; 368(10):924-35.
9.	O'Donnell BF et al. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997; 136(2): 197–201.
10.	Sussman G, Hébert J, Barron C, et al. Real-life experiences with omalizumab for the treatment of chronic urticaria, American College of Allergy, Asthma and Immunology. 2014; 170-174.
11.	Ben-Shoshan M, Blinderman I, Raz A. Psychosocial factors and chronic spontaneous urticaria: a systematic review. Allergy 2013; 68: 131-141.
12.	Kulthanan K, Jiamton S, Thumpimukvatana N, et al. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007;34:294–301.
13.	Zazzali JL, Broder MS, Chang E, Chiu MW, Hogan DJ. Cost, utilization, and patterns of medication use associated with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2012;108:98-102.
14.	Delong LK, Culler SD, Saini SS, Beck LA, Chen SC. Annual direct and indirect health care costs of chronic idiopathic urticaria: a cost analysis of 50 nonimmunosuppressed patients. Arch Dermatol. 2008;144:35-9.

SOURCE: Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Andrea Gilpin, Director, Corporate Communications, Novartis Pharmaceuticals Canada Inc., [phone], [email protected]; Rob McEwan, Vice President, Argyle Communications, + 1 416 968-7311 ext. 242, [email protected]