Posted by Michael Wonder on 08 Jul 2016
Novartis announces FDA approval of Xolair (omalizumab) for paediatric allergic asthma
7 July 2016 - Extension of indication makes Xolair the first and only approved biologic for pediatric patients six years and older with uncontrolled moderate to severe persistent allergic asthma.
Novartis today announced that the US FDA has approved an expanded age range for Xolair (omalizumab) to include children six to 11 years of age with moderate to severe persistent asthma, having a positive skin test or in vitro reactivity to an airborne allergen (perennial aeroallergen) and symptoms that are inadequately controlled with inhaled corticosteroids.
The previous age range for the asthma indication of Xolair was 12 years and older. This approval comes three months ahead of the FDA action date.
