Pharmaprojects R&D Pipeline News Feed
Positive Phase III results for Novartis' indacaterol
27 May 2009
Novartis has reported positive results from three pivotal Phase III trials for its investigational bronchodilator indacaterol (QAB-149), a once-daily inhaled long-acting ß2 agonist, under development for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.
Results from the trials (INVOLVE, INHANCE, and INLIGHT-1) demonstrated significantly improved lung function as measured by improvement in FEV1, compared to the currently approved COPD treatments formoterol and tiotropium, following three months of treatment with indacaterol. Indacaterol also showed improved symptom control (cough, wheezing and breathlessness) and was well tolerated at all doses with a good safety profile.
Further results from the three studies are expected later this year. Indacaterol is currently awaiting approval in the EU and US for COPD. Pending approval, it could be the first clinically relevant once-daily bronchodilator to have a 5-minute onset of action.
