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Clinical studies with omalizumab have been completed in pediatric patients 6 to < 12 years of age and updates made to the package labeling in January 2010. Although omalizumab-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose), other efficacy variables such as nocturnal symptoms scores, beta-agonist use, and measures of airflow (FEV1) were not significantly different bwtween omalizumab-treted patients compared to placebo. Considering the risk of anaphylaxis an malignancy seen in omalizumab-treated patients greater than 12 years old and the modest efficay of omalizumab in a pivotal pediatric study, the risk-benefit assessment does not support the use of omalizumab in patients 6 to <12 years of age.

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