• Giuseppe Tridente


Omalizumab (Xolair®, Genentech) is a recombinant humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). This monoclonal was first registered by TGA in Australia in June 2002 for the treatment of moderate to severe allergic asthma (AA) resistant to inhaled steroids, and with IgE levels corresponding to the recommended dose range. Following a previous rejection in 2001, FDA granted approval in 2003 for adults and adolescents (≥12 years) with moderate to severe persistent asthma, positive to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. In October 2005, a marketing authorization was granted by EMEA for the treatment of AA in patients (≥12 years) in whom standard treatment had failed. In December 2005, TGA extended the registration to include management of adult and adolescent patients with moderate to severe AA, who are already being treated with inhaled steroids and have IgE levels corresponding to the recommended dose range. In June 2009, EMEA extended the indication as add-on therapy in young patients (6 to <12 years of age) affected by severe persistent AA with positive skin test or in vitro reactivity to a perennial aeroallergen, frequent daytime symptoms or nighttime awakenings, and multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.


Food Allergy Allergic Asthma Chronic Urticaria Seasonal Allergic Rhinitis Systemic Mastocytosis 
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Supplementary material

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Supplementary material 1 (XLS 66 kb)


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Copyright information

© Springer-Verlag Italia 2014

Authors and Affiliations

  1. 1.University of VeronaVeronaItaly

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