FDA Accepts Supplemental Biologics License Application for Pediatric Allergic Asthma Drug


BLA for omalizumab (Xolair) is indicated for children aged 6 to 11 years with moderate-to-severe persistent asthma.

The FDA has accepted a supplemental Biologics License Application (sBLA) for the extension of omalizumab (Xolair) to include pediatric patients with allergic asthma, a disease that affects 7 million children in the United States.

Omalizumab will be reviewed by the FDA for children 6 to 11-years-old with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to an airborne allergen and symptoms that are not adequately controlled with inhaled corticosteroids.

"Childhood allergic asthma often remains uncontrolled despite the use of inhaled steroids," said Chief Medical Officer and Head of Global Product Development Sandra Horning, MD. "The disease can significantly impact a child, and this filing acceptance brings us one step closer to addressing this significant unmet need."

In 2003, omalizumab was approved for patients aged 12 years and older. It was approved again in 2014 for adults and children 12 years and older with chronic idiopathic urticarial (CIU) who still had hives despite treatment with H1-antihistamine.

Since omalizumab’s launch, more than 200,000 patients 12 years and older with allergic asthma were treated.

The sBLA is supported by a phase 3 randomized, double-blind, placebo controlled, and multi-center 52 week trial with the primary endpoint at 24 weeks.

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