The U.S. Food and Drug Administration (FDA) has expanded the allowable age range for the omalizumab asthma treatment to children between 6 and 11 years old.
The treatment, given by injection and known by the brand Xolair, is used to treat moderate to severe persistent asthma that has an allergic basis and is not adequately controlled by inhaled corticosteroid drugs.
“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,” said Fabrice Chouraqui, president of Novartis Pharmaceuticals, which produces Xolair.
The new approval in children follows clinical studies in multiple centers. Previously omalizumab was approved for those with the condition over the age of 12.
“Uncontrolled allergic asthma can significantly affect the lives of children,” said Dr. Cary Sennett, 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.”