Omalizumab in asthma: approval and postapproval experience.

Omalizumab is a humanized mouse monoclonal antibody that binds specifically to the constant region of the immunoglobulin (Ig)E heavy chain. Omalizumab exerts its effects by reducing free serum IgE levels and FcepsilonRI expression on several cell types. These effects have been shown to result in decreased airway inflammation and clinical improvement. In multiple studies, omalizumab has been shown to be efficacious in the treatment of moderate-to-severe persistent asthma and is currently approved by the US Food and Drug Administration for the treatment of moderate-to-severe allergic asthma in patients age 12 yr and older. Moreover, omalizumab has been demonstrated to be effective in the treatment of children and adults with seasonal and perennial allergic rhinitis. Postmarketing surveillance has shown omalizumab to be a relatively safe and well-tolerated medication.