Genentech announced that the FDA has approved Xolair (omalizumab) injection for the treatment of chronic idiopathic urticaria (CIU) in patients ≥12 years of age who remain symptomatic despite H1-antihistamine therapy.

Xolair, an IgE blocker, is the first biologic approved for CIU since non-sedating H1-antihistamines. It binds to IgE and lowers free IgE levels, which causes IgE receptors (FcεRI) on cells to down-regulate. The mechanism by which these effects of omalizumab result in an improvement of CIU symptoms is unknown.

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Safety and efficacy of Xolair for the treatment of CIU was studied in two studies called ASTERIA I and ASTERIA II. Patients aged 12–75 years received Xolair at 150mg, 300mg or placebo every 4 weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In ASTERIA I, Xolair 150mg improved itch severity score (ISS) from the baseline by 47% (-6.7) and Xolair 300mg improved ISS from baseline by 66% (-9.4) at Week 12 vs. 25% (-3.6) score improvement for patients who received placebo. Similar results were seen with ASTERIA II.

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Xolair is already approved for use in moderate to severe persistent asthma in patients with a (+) skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids.

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