Novartis Announces FDA Approval of Xolair for Pediatric Allergic Asthma

East Hanover, NJ – Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded age range for Xolair (omalizumab) to include children 6-11 years of age with moderate to severe persistent asthma, having a positive skin test or in vitro reactivity to an airborne allergen (perennial aeroallergen) and symptoms that are inadequately controlled with inhaled corticosteroids. The previous age range for the asthma indication of Xolair was 12 years and older. This approval comes 3 months ahead of the FDA action date.

“Allergic asthma can be challenging for children,” said Fabrice Chouraqui, president of Novartis Pharmaceuticals Corporation. “For a long time, there has been an unmet need in this young patient population. We’re excited to now offer this allergic asthma treatment option, which has been established in patients 12 years of age and older, to doctors and their young patients starting at age 6.”

Asthma is one of the most common long-term diseases in children, affecting about 6.3 million younger than 18 years old or one in 12 children in the U.S. An estimated 24 million people in the U.S. have asthma. Of this patient population, approximately 60% have allergic asthma. In children, at least 80% of asthma is allergic.

“Uncontrolled allergic asthma can significantly affect the lives of children,” said Cary Sennett, MD, PhD, president and CEO of the Asthma and Allergy Foundation of America (AAFA). “This approval helps address an important unmet need for these young patients and their caregivers.”

Xolair was first approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids. Since its U.S. approval for patients 12 years and older, more than 200,000 patients with allergic asthma have been treated with the medicine. 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).

This new pediatric approval was supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children aged 6-11 years with moderate to severe persistent uncontrolled allergic asthma. The primary study was a 52-week trial, with the primary endpoint measured at 24 weeks. Supportive safety and efficacy data came from a 28-week study. Additional safety data came from a five-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients 12 years and older.

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