Roche Group member Genentech has received the Food and Drug Administration (FDA) approval for Xolair (omalizumab) to treat children with moderate to severe persistent allergic asthma.
Allergic Asthma is caused by exposure to year-round allergens in the air and is a chronic disease that activates inflammation and narrowing of the airways, along with tightening of the muscles around the airways.
Xolair (omalizumab) is used to treat allergic asthma patients between six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen, as well as show symptoms that are inadequately controlled with inhaled corticosteroids.
Genentech global product development chief medical officer and head Dr Sandra Horning said: “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 aged six and older.”
In 2003, Xolair was first approved to treat adults and children of 12 years of age and above, who are affected with moderate to severe persistent allergic asthma not controlled by inhaled steroids.
Xolair is not indicated to treat allergic conditions such as acute bronchospasm, serious and sudden breathing problems, and status asthmaticus (acute, severe, prolonged asthma attack that can be life-threatening).
In the US, Genentech and Swiss-based pharmaceutical company Novartis Pharmaceuticals work together to develop, as well as co-promote Xolair.