Asthma is big business for Big Pharma. Advair was the third bestselling drug in the world in 2013 and the asthma drugs Singulair and Symbicort were also blockbusters. So it is no surprise the prospect of a high-tech injectable drug that stops an allergic response by binding to Immunoglobulin E (IgE) made Big Pharma sit up and take notice.
Xolair (omalizumab), developed from humanized rodent cells (yes, you read that right), is part of Big Pharma’s new wave of bio-engineered liquid drugs, rolled out when blockbusters like Lipitor and Viagra went off patent. Injected drugs/biologics can earn $20,000 or more per patient per year and are resistant to the quick generic competition that threatens easier-to-replicate pills. Currently, biologics Humira and Enbrel are bestselling drugs.
Novartis and Genentech, which decided to co-market Xolair, sought FDA approval for four conditions in 2001—pediatric and adult asthma, and pediatric and adult seasonal allergic rhinitis symptoms (SARS). But the FDA only approved Xolair to treat one, in 2013—“moderate to severe persistent asthma” in patients over 12 whose symptoms are “not adequately controlled on inhaled corticosteroids” and who have a positive skin test or reactivity to an allergen.
