FDA Approves Novartis`s Xolair for Age Range Expansion

The FDA has just announced that Novartis’s (NYSE: NVS) Xolair (omalizumab) has been approved to expand its age range to include children 6-11 years of age with moderate to severe persistent asthma. This approval comes three months ahead of the FDA action date.

These children must also have a positive skin test or in vitro reactivity to an airborne allergen (perennial aeroallergen) and symptoms that are inadequately controlled with inhaled corticosteroids. 

“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.”

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 six to 11 years with moderate to severe persistent uncontrolled allergic asthma. —Amanda Del Signore