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Study Shows Potential Benefits of Xolair(R) in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids
Date:11/8/2008

- Results demonstrate clinically significant reduction in allergic asthma attacks and further define Xolair safety profile in children age six through 11 - this includes 11-year-old children, up to their 12th birthday

- Xolair is the only approved therapy to block IgE, which is associated with approximately 78% of childhood asthma

- Allergic asthma affects 2.5 million children in the US under the age of 18

- Xolair is currently approved for adults and adolescents aged 12 and above; US submission to treat children aged six through 11 planned

SEATTLE, Nov. 8, 2008 /PRNewswire/ -- Data presented today at the American College of Allergy, Asthma & Immunology (ACAAI) show that Xolair(R) (Omalizumab) for Subcutaneous Use significantly reduced asthma attacks in children aged six through 11 with moderate or severe persistent allergic asthma inadequately controlled with inhaled corticosteroids. The study further defines the safety profile of Xolair in this patient population.

The Phase III study showed that children treated with Xolair demonstrated a 31% reduction in clinically significant asthma exacerbations compared to children treated with placebo at 24 weeks. After a year of treatment, children treated with Xolair suffered 43% fewer clinically significant asthma exacerbations than those receiving placebo.

Xolair is a biologic treatment currently approved for people 12 years of age and above with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. It is the only approved therapy which blocks IgE (immunoglobulin E), a major component of allergic asthma. Genentech, co-marketer of Xolair, plans to submit these data to the US Food and Drug Administration (FDA) seeking to expand the current labeled indication for Xolair.

"Asthma is a life-threatening disease that can have serious h
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SOURCE Novartis Pharmaceuticals Corporation
Copyright©2008 PR Newswire.
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