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Novartis is to review data already submitted to the US Food and Drug Administration (FDA) regarding dosage for its QAB149 treatment for chronic obstructive pulmonary disease (COPD), also known as smoker’s lung.
Says Trevor Mundel, global head of development at Novartis Pharma: “Our confidence in the benefit/risk profile of QAB149 is based on results of Phase III trials which showed QAB149 significantly improved lung function.”
He says that the company will work with the FDA to review the data to determine whether further clinical trials are needed, and if so, how they should be regulated.
QAB149, also known as indacaterol, is the first once-daily bronchodilator treatment. The European Medicines Agency has backed approval of the drug, a recommendation likely to be followed by the European Commission when it delivers its final decision.
While Novartis will sell QAB149 as a monotherapy, industry analysts believe the medicine’s full sales potential may depend on combining it with other treatments.
Copyright Press Association 2009