Novartis’ Xolair (omalizumab) Receives EU’s Approval for Severe Allergic Asthma (SAA) and Chronic Spontaneous Urticaria (CSU)

• The approval is based on trial results assessing Xolair IV (q2w or q4w) in 1M patients with SAA and CSU for 13 years
• The study demonstrated in reduction of severe exacerbations, corticosteroid use in SAA patients and reduction in symptoms of CSU with safe and well-tolerated results
• Xolair (omalizumab) is a prefilled syringe (PFS) self-administered syringe, used for targeting  IgE and is approved by EU and the US FSA for moderate-to-severe or severe persistent allergic asthma in 2005 & 2003 respectively

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