Novartis delivers promising Ph3 data for combo COPD treatment

Novartis has unleashed a new batch of promising late-stage data for its blockbuster hopeful Onbrez Breezhaler, noting that COPD patients responded better on a combo with Pfizer's Spiriva HandiHaler when compared to the Pfizer treatment alone. The data fits in neatly with analysts' projections that the treatment won't achieve peak blockbuster sales unless it's used in a combo approach.

"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 Novartis development chief Trevor Mundel.

While Onbrez--indacaterol, or originally QAB149--is approved in Europe, U.S. regulators aren't scheduled to finish their review before July. The FDA threw up a roadblock on the program in 2009 when it demanded to see more information on the drug before an approval. The new Phase III data also underscores a big trend among developers, who have been more aggressive about providing comparative effectiveness data for payers evaluating which treatments should be encouraged for patients. The findings were presented at the American Thoracic Society congress in Denver.

"The internationally recognized GOLD guidelines state that combining bronchodilators with different modes of action may provide improved efficacy with no increase in side effects," said the principal investigator Donald A. Mahler, MD, of the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, USA. "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."

- here's the Novartis release
- check out the Reuters story