Pharmaceutical Business review

Novartis Provides Results From Phase III Trial Of QAB149

Novartis has reported results from phase III trial showing QAB149 (indacaterol) significantly improves lung function and provides reduction in breathlessness compared to tiotropium, a current treatment option.

QAB149 (indacaterol), an investigational once-daily bronchodilator for chronic obstructive pulmonary disease (COPD). The data were presented at the European Respiratory Society (ERS) 2009 Annual Congress in Vienna.

Reportedly, at 12 weeks of treatment, QAB149 150µg and 300µg improved trough FEV1, a key measure of lung function, by 50ml and 40ml respectively, over tiotropium 18µg. New data showed at week 26, that patients on QAB149 300µg continued to show greater improvement in trough FEV1 than tiotropium.

Additionally, further new data showed that a higher proportion of patients treated with QAB149 achieved a significant clinically relevant improvement in their symptoms of breathlessness, compared to tiotropium.

Patients on QAB149 also had a highly significant greater than 20% increase in days during which no ‘relief’ medication therapies used to treat acute episodes of severe breathlessness, was required compared to patients treated with tiotropium.

QAB149 is currently undergoing regulatory review in the EU, the US and other countries around the world for the treatment of COPD. The Data presented on all evaluated doses of QAB149 highlights a good overall safety and tolerability profile.

Trevor Mundel, global head of development at Novartis, said: “QAB149 has the potential to be recognised as the best bronchodilator for COPD by providing patients with significantly greater lung function improvement and reductions in breathlessness compared to other bronchodilators. We also plan for QAB149 to form the foundation of a new portfolio of products, designed to improve patients’ respiratory health.”