FDA to Review Xolair Pediatric Indication for Allergic Asthma

Genentech announced that the Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Xolair(omalizumab) to extend its indication in allergic asthma to pediatric patients.

The sBLA submission is based on data from multicenter, randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of Xolair in children 6–11 years old with moderate to severe persistent uncontrolled allergic asthma. The trial is conducted over 52 weeks, with the primary endpoint measured at 24 weeks.

Xolair is currently indicated for the treatment of moderate to severe persistent asthma in patients ≥12 years old with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. It is also approved for the treatment of adults and children ≥12 years with chronic idiopathic urticaria (CIU) – chronic hives without a known cause – who continue to have hives uncontrolled by H₁-antihistamine treatment.

Xolair is developed and co-promoted by Genentech and Novartis.

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