Xolair Gains Chronic Hives Indication
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.
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.
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.
For more information call (866) 496-5247 or visit Xolair.com.