Novartis will have to provide more information to the US Food and Drug Administration before it can get its chronic obstructive pulmonary disease investigational drug indacaterol onto the market.

The agency has issued the Swiss major with a complete response letter for QAB149 (indacaterol), a once-daily bronchodilator for the treatment of adults with COPD. The FDA has requested additional information on the dosing proposed for the drug and Novartis said it will work with the agency to review already submitted and recently available data “to determine what, if any, further clinical trials would be required”.

Trevor Mundel, head of development at Novartis, does not seem too concerned and spoke of "our confidence in the benefit/risk profile of QAB149”. That confidence is is based on results of Phase III trials which showed that indacaterol significantly improved lung function and provided “clinically relevant improvement in symptoms such as breathlessness compared to other bronchodilators”, he added.

Last month, Novartis presented more late-stage data on indacaterol which the Swiss major says show significant benefits over Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium). Regulators in Europe seem to like the look of QAB149 and three weeks ago the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the treatment, which would be sold as Onbrez Breezhaler.