FDA approves new Xolair indication

SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Xolair (omalizumab), Genentech  and Novartis, which work together to develop and co-promote the drug in the U.S., announced. 

 

Xolair can now be used in patients 6 to 11 years of age with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to airborne allergens and whose symptoms are controlled adequately by corticosteroids. The drug had previously been approved to treat allergic asthma in patients 12 years of age and older. 

 

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