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Major Pharma Scandal: Whistleblowers Claim Popular Asthma Drug Was Marketed Illegally

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big-pharma-fdaAsthma is big business for Big Pharma. Advair was the third best selling 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 as much as $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.

A biologic that could treat asthma sounded so lucrative, Novartis actually sued Genentech, which was developing a similar drug to its own for “trade secret” violations until the drug giants decided to team up and sell Xolair together.

They no doubt regretted their optimism.

Though Novartis and Genentech sought FDA approval for four conditions in 2001—pediatric and adult asthma and pediatric and adult seasonal allergic rhinitis symptoms (SARS)—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.

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