Genentech recently announced that its supplemental Biologics License Application (sBLA) for extension of Xolair (omalizumab) in allergic asthma in pediatric patients has been accepted by the U.S. Food and Drug Administration (FDA).
The final decision, which is expected to be made later this year, will determine whether Xolair can be used in children ages 6 to 11 for the treatment of moderate to severe persistent asthma, particularly in patients with a positive skin test or in vitro reactivity to an airborne allergen, with symptoms that are not manageable with inhaled corticosteroids.
According to the American College of Allergy, Asthma and Immunology, asthma affects 19 million adults and 7 million children in the U.S., and is one of the leading causes of absences from work and school. The number of people diagnosed with asthma is increasing, with allergic asthma being the most common form of the disease.
Xolair is an injectable prescription medicine approved by the FDA in 2003 for moderate to severe persistent asthma that is not controlled by common asthma medicines (inhaled corticosteroids) in adults and children older than 12. In was approved again by the FDA in 2014 for the treatment of adults and children older than 12 with chronic idiopathic urticaria (CIU) that is not controlled by common medicines.
Since its launch, more than 200,000 patients with allergic asthma have been treated with Xolair in the U.S.
Genentech’s sBLA is supported by data from multicenter, placebo-controlled, phase 3 clinical trials that have assessed Xolair’s efficacy and safety in treating children ages 6 to 11 with moderate to severe persistent uncontrolled allergic asthma. Additional supportive data comes from a five-year observational post-marketing study that evaluated the long-term safety of Xolair in patients 12 and older.
“Childhood allergic asthma often remains uncontrolled despite the use of inhaled steroids,” Sandra Horning, M.D., Genentech chief medical officer and head of global product development, said in a press release. “The disease can significantly impact a child, and this filing acceptance brings us one step closer to addressing this significant unmet need.”