US regulators have approved an expanded age range for Novartis/Genentech's Xolair, giving younger children with moderate to severe persistent asthma a new option to help control their disease.
Xolair (omalizumab) was first approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids, and the following year for chronic hives in patients failing to respond to H1-antihistamine treatment.
The US Food and Drug Administration is now also allowing the drug's use in 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 aeroallergen (perennial aeroallergen) and symptoms that are inadequately controlled with inhaled corticosteroids.
Asthma is one of the most common long-term diseases in children, affecting around 6.3 million people under 18 or one in 12 children in the US alone. Around 60 percent have allergic asthma, and the American Academy of Paediatrics estimates that between 70 and 80 percent of school-aged children with asthma also have allergies, which are among the most common triggers for the condition.
"Allergic asthma can be challenging for children. For a long time, there has been an unmet need in this young patient population," noted Fabrice Chouraqui, president of Novartis Pharmaceuticals Corp.
"Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children. With this approval, we're pleased to see a proven treatment option is now available for appropriate patients six and older," said Sandra Horning, chief medical officer and head of Global Product Development, Genentech.
The expanded approval was backed by data from multi-center, randomized, double-blind, placebo-controlled, Phase III studies showing Xolair's ability to reduce asthma exacerbations in children aged six to 11 inadequately controlled on other medications, with a 43 percent relative rate reduction over the 52-week treatment period.