Omalizumab for asthma: pharmacology and clinical profile.

Asthma remains uncontrolled in a significant minority of patients despite apparently optimal therapy with conventional inhaled agents. Omalizumab, the first 'biological' therapy of asthma, has emerged as a potentially useful therapy of moderate-to-severe atopic asthma. When administered subcutaneously every 2-4 weeks, omalizumab binds to circulating IgE, preventing the interaction of IgE with high-affinity receptors. Placebo-controlled trials show that its use reduces exacerbation frequency, thereby allowing decreases in the dosage of inhaled or oral steroids, while improving health status (i.e., quality of life). This article reviews the pharmacological aspects of this medication, the clinical studies supporting its use and the recent safety concerns highlighted by the US FDA.