FDA approves Genentech’s Xolair for allergic asthma in children

Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma.

"Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children," said Sandra Horning, chief medical officer and head of Global Product Development. "With this approval, we’re pleased to see a proven treatment option is now available for appropriate patients six and older."

"Uncontrolled allergic asthma can significantly affect the lives of children," said Cary Sennett, president and CEO of the Asthma and Allergy Foundation of America (AAFA). "This approval helps to address an important unmet need for children older than six and their parents or 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 US approval, more than 200,000 patients older than 12 with allergic asthma have been treated with the medicine. Xolair is not indicated for the treatment of other allergic conditions, acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life-threatening).

The latest approval is supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children from six to 11 years old 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 come from a 28-week study. Additional safety data come from a 5-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients 12 years and older.