Novartis receives European Commission approval for self-administration of Xolair across all indications - Seite 2

"Today's positive news is a big step forward for patients living with immunoglobulin E- mediated asthma and chronic spontaneous urticaria. Decreasing the number of regular clinic visits allows patients the flexibility to fit their treatment around their lives and helps to reduce the burden of these diseases. It also allows physicians a greater capacity for patients who need extra care, which is important" said Professor Dr. Karl-Christian Bergmann, Allergy Center Charité, Berlin.

Administered via injection every two or four weeks, Xolair is widely used and well tolerated[6]. With 13 years of physician experience in Europe and one million patient years of exposure, use of Xolair in SAA and CSU is supported by a wealth of evidence from randomized clinical trials and real-world studies[1]-[3]. Anaphylactic reactions were rare in clinical trials (>= 1/10,000 to < 1/1,000)[5] and via post-marketing reports (approximately 0.2 percent)[5].

About Allergic Asthma and Chronic Spontaneous Urticaria
Asthma is a serious and chronic lung disease affecting an estimated 235 million people around the world[7]. It causes swelling and narrowing of the airways, making breathing difficult[7]. Allergic asthma, the most common form of asthma, accounts for approximately 60 percent of asthma cases[8],[9].

Urticaria is a severe disease characterized by persistent hives and/or painful deeper swelling of the skin tissue (angioedema). When this persists for 6 weeks or more, it is classified as chronic urticaria[10]. Chronic spontaneous urticaria (CSU), also called chronic idiopathic urticaria (CIU), is identified as the appearance of hives and/or angioedema without an identifiable trigger for more than 6 weeks[10]. Most patients with CSU remain symptomatic for more than one year, but in some patients, symptoms may persist for decades[10].

About Xolair
Xolair (omalizumab) is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

As an injectable prescription medicine, Xolair is approved for the treatment of moderate-to-severe or severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005. Xolair is approved for the treatment of CSU in over 80 countries including the European Union and for chronic idiopathic urticaria (CIU), as it is known in the US and Canada. Xolair has over one million patient years of exposure. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and more than 10 countries outside of the EU, including Canada, the US, and Australia. In the US, Novartis and Genentech, Inc. work together to develop and co-promote Xolair. Outside the US, Novartis markets Xolair and records all sales and related costs.