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7-month, prospective, randomized, placebo-controlled double-blind trial of omalizumab in children with allergic asthma who require daily corticosteroid treatment

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Trial Profile

7-month, prospective, randomized, placebo-controlled double-blind trial of omalizumab in children with allergic asthma who require daily corticosteroid treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2016

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Allergic asthma
  • Focus Therapeutic Use

    • Most Recent Events

    • 07 Jul 2016 Results published in a Genentech media release.
    • 07 Jul 2016 According to a Genentech media release, t0he US FDA has approved omalizumab (Xolair) for the treatment of moderate to severe persistent asthma in children six to 11 years of age. The approval was supported from by data from this and other phase III trials.
    • 01 Mar 2016 According to a Genentech media releae, the US FDA has accepted for review the company's supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients. The sBLA was supported by this and other phase III trials.
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