Data presented at the 2011 American Thoracic Society (ATS) meeting by Novartis regarding combined indacaterol and tiotropium therapy for COPD demonstrate that the LABA/LAMA combination produced greater improvement in lung function than tiotropium alone.
Novartis’s indacaterol product, called Onbrez Breezhaler, was approved by the EU in 2009 but has not yet been approved in the US. The FDA has extended its review period until July 2011.
“Previous studies have demonstrated the safety and efficacy profile of Onbrez Breezhaler as monotherapy in COPD, and the latest results indicate that it may have even greater therapeutic potential when combined with another leading class of treatment,” said Trevor Mundel, Global Head of Development at Novartis Pharma AG. “These studies add to the comprehensive data supporting Onbrez Breezhaler as an effective treatment for COPD with a good overall safety profile.”
The INTRUST 1 and 2 12-week randomized, double-blind studies each involved more than 1,100 patients with moderate-to-severe COPD as defined by the GOLD 2007 criteria. All subjects use 18 mcg tiotropium once daily. In addition, one group of patients received 150 mcg indacaterol once daily, and another group received a placebo.
According to principal investigator Donald A. Mahler of the Dartmouth-Hitchcock Medical Center, “These are the first 12-week studies to report on the efficacy of two once-daily bronchodilators given concurrently, and the results confirm that the GOLD recommendation holds true for the use of indacaterol plus tiotropium.”
Read the Novartis press release.
