Novartis announced that the Food and Drug Administration (FDA) has approved an expanded age range for Xolair (omalizumab) to include children aged 6–11 years with moderate to severe persistent asthma with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids. 

Prior to this approval, Xolair for asthma was indicated for use in patients aged ≥12 years. In 2014, the FDA also approved Xolair for the treatment of chronic idiopathic urticaria (CIU) with symptoms uncontrolled by H1-antihistamines in patients aged ≥12 years. 

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The expanded pediatric approval was supported by data from Phase 3 multi-center, randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of Xolair in children aged  6–11 years with moderate to severe persistent uncontrolled allergic asthma. In the 52-week trial, the primary endpoint was assessed at 24 weeks.

Xolair, an IgE blocker, works by inhibiting the binding of IgE to the high-affinity IgE receptor on the surface of mast cells and basophils. Reduction in surface-bound IgE on FcεRI-bearing cells limits the degree of release of mediators of the allergic response.

Xolair is available as a 150mg per vial strength powder for subcutaneous injection.

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