Novartis has presented initial data from three late-stage trials of its investigational chronic obstructive pulmonary disease drug indacaterol which the Swiss major says show significant benefits over two leading current treatments.

The data, which was presented at the American Thoracic Society meeting in San Diego, revealed that all doses of indacaterol, also known as QAB149, were well-tolerated with a good overall safety profile in the three Phase III trials – INVOLVE (1 year), INHANCE (6 months) and INLIGHT-1 (3 months). The results also revealed that the drug showed improved lung function compared to Boehringer Ingelheim/Pfizer’s blockbuster Spiriva (tiotropium) and Novartis’ own Foradil (formoterol) at three months of treatment.

Novartis also said the three trials demonstrated that indacaterol could be the first once-daily bronchodilator to combine clinically relevant 24-hour relief with onset of action within five minutes. QAB149 is currently under regulatory review in the European Union and the USA and if approved, the Basel-based group says it could “become the foundation of a Novartis portfolio of products, including fixed-dose combinations, designed to address unmet needs in respiratory care”.

The data was disclosed just after Novartis renegotiated a collaboration with Schering-Plough and assumed responsibility for development of a once-daily drug that combines indacaterol with S-P's Asmanex (mometasone). In return, the latter firm has gained exclusive rights to develop and commercialise a fixed-dose combination of Asmanex with Foradil.

Benefits of Symbicort added to Spiriva
Also at the ATS meeting, data was presented which demonstrated that Spiriva added to AstraZeneca’s Symbicort (budesonide/formoterol) provided greater clinical improvements than tiotropium alone over a 12-week treatment period.

Results from the CLIMB study showed that the occurrence of severe exacerbations was reduced by as much as 62% in patients with severe COPD where budesonide/formoterol was added to tiotropium compared to just Spiriva. The data also demonstrated that patients on Spiriva plus Symbicort experienced greater relief from morning breathlessness, improved ability to carry out morning activities and, a reduced need for relief medication.

The benefits were evident after just one week of treatment and importantly further improved over the duration of the trial.