FDA approves Genentech's Xolair allergic asthma in younger children

The US Food and Drug Administration has approved Xolair (omalizumab), from Roche (ROG: SIX) subsidiary Genentech, to treat moderate to severe persistent asthma in children six to 11 years of age, who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids.

Xolair, which in the USA is co-promoted by Genentech and Novartis (NOVN: VX), is already approved to treat people 12 years and older with allergic asthma. Despite first being approved for use in children aged 12 and over in 2003, Xolair is still a growing product for Roche, with 2015 sales up 25% at 1.28 billion Swiss francs ($1.32 billion).

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