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Pharmaceutical industry

European Commission Approves Xolair for Severe Allergic Asthma Treatment

Strategic Insights

— 1 min read

The European Commission has authorized the treatment of severe allergic asthma with Xolair (omalizumab) in all 25 European Union member states. Developed by Tanox, Inc., Genentech, and Novartis Pharma AG, Xolair is a humanized therapeutic antibody that targets IgE, a key cause of inflammation and symptoms in allergic diseases. The treatment has already been approved in other countries, including Australia, Brazil, Canada, and Venezuela, and is expected to be available in European markets soon.

Key Takeaways:

  • Xolair is a humanized therapeutic antibody approved for the treatment of severe allergic asthma in Europe, with a focus on blocking the action of IgE.
  • Clinical studies have shown that Xolair significantly reduces the rate of asthma exacerbations in patients with moderate-to-severe persistent allergic asthma.
  • The therapy is prescribed to patients who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
  • Xolair is administered by subcutaneous injection every 2 or 4 weeks and is approved for use in adults and adolescents (12 years of age and above) with severe persistent allergic asthma.
  • Tanox, the developer of Xolair, receives royalties on sales of the therapy and a share of Novartis' net profits on sales in the U.S.
  • Xolair is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand, and Venezuela, and is co-marketed in the U.S. by Genentech and Novartis.

Statistics:

  • The European Commission has approved Xolair for the treatment of severe allergic asthma in all 25 European Union member states.
  • Xolair was approved by the Food and Drug Administration (FDA) in June 2003 for subcutaneous use for the treatment of adults and adolescents (12 years of age and above) with moderate-to-severe persistent allergic asthma.
  • Clinical studies have shown that Xolair significantly reduces the rate of asthma exacerbations (attacks) in patients with moderate-to-severe persistent allergic asthma.
  • Xolair is administered by subcutaneous injection every 2 or 4 weeks.
  • Tanox receives royalties on sales of Xolair and a share of Novartis' net profits on sales in the U.S.

Sources:

  • European Commission
  • Tanox, Inc. (TNOX)
  • Genentech, Inc.
  • Novartis Pharma AG
  • Food and Drug Administration (FDA)
  • Health & Medicine Week
  • NewsRx.com

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