Compound Name:OmalizumabMolecular Target:IgEMolecular Structure:humanized IgG1?, recombinantLicensed Indication:moderate to severe IgE-mediated, persistent asthma (US) or severe asthma (EU), in adults and children over 12 years old, inadequately controlled by inhaled corticosteroid treatmentManufacturer and/or Distributor:Genentech & NovartisInitial FDA Approval:2003Summary:Omalizumab is a recombinant humanized IgG1κ monoclonal antibody that binds specifically to circulating, but not cell-bound, human IgE. As a result, native IgE is inhibited from binding to the high-affinity IgE receptor (FcεRI) present on mast cells and basophils, reducing the release of allergic mediators. The number of FcεRI on basophils also decreases. It is administered subcutaneously every two to four weeks for asthma treatment and every 4 weeks for chronic urticaria. Omalizumab was licensed in 2003 for the treatment of moderate to severe persistent asthma in patients older than 12, who had a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. It has been shown to be effective in decreasing corticosteroid use and number of asthma exacerbations experienced. In 2014, the FDA approved its use for chronic idiopathic urticaria. Omalizumab should not be used for the treatment of acute exacerbations. Particular safety concerns are anaphylaxis, heart attacks, serum sickness, and eosinophilic conditions. A five-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with omalizumab compared to those patients not treated with omalizumab.References

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