FDA accepts Genentech’s sBLA to extend indication of Xolair 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 children1, affecting about seven million or one in 10 children in the U.S.2,3. Approximately 25 million people in the U.S. have asthma4, 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 medicine6.

In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients’ lives.

Development Program

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. 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 patients12 years9 and older.

About Xolair

Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:

moderate to severe persistent asthma whose symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens.
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 used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.