Genentech, a member of Swiss drug maker Roche Holding AG (RHHBY), said that the U.S. Food and Drug Administration has accepted for review the company's supplemental Biologics License Application or sBLA to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients.
The FDA will review Xolair in children from six through 11 years for the treatment of moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Genentech anticipates hearing from the FDA later this year.
Genentech noted that the sBLA is supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children aged six to 11 years with moderate to severe persistent uncontrolled allergic asthma
Asthma is the leading chronic disease in children, affecting about seven million or one in 10 children in the U.S. About 25 million people in the U.S. have asthma, with allergic asthma being the most common form of the disease.
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