FDA files Genentech’s sBLA of Xolair for pediatric allergic asthma
Genentech, a member of the Roche Group, has announced the FDA 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 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.
“Childhood allergic asthma often remains uncontrolled despite the use of inhaled steroids,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The disease can significantly impact a child, and this filing acceptance brings us one step closer to addressing this significant unmet need.”
Asthma is the leading chronic disease in children, affecting about seven million or one in 10 children in the U.S. Approximately 25 million people in the U.S. have asthma, with allergic asthma being the most common form of the disease.
Xolair was approved in 2003 in the U.S. for moderate to severe persistent asthma in patients 12 years of age and above with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. In 2014, the FDA also approved Xolair to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU) —chronic hives without a known cause—who continue to have hives that are not controlled by H1-antihistamine treatment. Xolair is not indicated for the treatment of other allergic conditions, other forms of urticaria (hives), acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life-threatening). Since the launch of Xolair, more than 200,000 patients 12 years of age and older with allergic asthma in the U.S. have been treated with the medicine.
In the U.S., Genentech and Novartis Pharmaceuticals work together to develop and co-promote Xolair.
The sBLA is supported by multicenter, 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. The primary study is a 52-week trial, with the primary endpoint measured at 24 weeks. Supportive safety and efficacy data comes from a 28-week study. Additional safety data come from a five-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients 12 years and older.