Breaking News From Pharma & Bio Ingredients
Xolair Receives Approval in Europe
Posted on 2005-10-27 09:06:00
The European Commission has approved Xolair (omalizumab) for the treatment of severe allergic asthma in all 25 European Union member states. Xolair, developed under an agreement between Tanox, Inc., Genentech, Inc. and Novartis Pharma AG, is expected to be available in initial EU markets within the next few weeks.
Xolair is the first humanized therapeutic antibody to be approved for the treatment of allergic asthma, and offers a unique therapeutic approach by blocking the action of IgE, an underlying cause of inflammation and resulting symptoms in allergic disease.
"Xolair has the potential to transform the lives of patients who suffer from severe allergic asthma by reducing the number of asthma attacks they experience," said Nancy Chang, Ph.D., Tanox president and chief executive officer.
"Since Xolair's approval in the U.S., we've seen how patients have benefited from its use. It's extremely rewarding to know that asthma sufferers in Europe will soon have access to the therapy."
The Food and Drug Administration approved Xolair 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. It 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 two or four weeks. Clinical studies have shown that Xolair significantly reduced the rate of asthma exacerbations (attacks). As of Sept. 30, 2005, Xolair had been prescribed to more than 50,000 patients. This first-in-class therapy is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela.
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