FDA Expands Omalizumab (Xolair) to Younger Kids With Allergic Asthma

Megan Brooks


July 11, 2016

The US Food and Drug Administration (FDA) has approved expanded use of omalizumab (Xolair, Novartis) to children as young as 6 years of age with uncontrolled moderate to severe persistent allergic asthma who have a positive skin test result or in vitro reactivity to an airborne allergen and symptoms that are inadequately controlled with inhaled corticosteroids, the company has announced.

Omalizumab was first approved in 2003 to treat adults and children age 12 years and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids. The expanded approval to children age 6 to 11 years comes 3 months ahead of the FDA action date, the company said.

"Allergic asthma can be challenging for children," Fabrice Chouraqui, president, Novartis Pharmaceuticals Corp, said in a news release. "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 six."

This expanded pediatric approval was supported by multicenter, randomized, double-blind, placebo-controlled phase 3 studies involving children age 6 to 11 years with moderate to severe persistent uncontrolled allergic asthma, the company said.

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

Omalizumab is also approved for the treatment of adults and children age 12 years and older with chronic idiopathic urticaria refractory to H1-antihistamine treatment. Omalizumab is not indicated for the treatment of other allergic conditions, other forms of urticaria, acute bronchospasm, or status asthmaticus.

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