Novartis has been boosted by the release of late-stage data which suggests that its chronic obstructive pulmonary disease treatment Onbrez provided greater clinical benefit than Boehringer Ingelheim/Pfizer's blockbuster Spiriva.
Results from the INTENSITY trial have been presented at the CHEST meeting of the American College of Chest Physicians in Vancouver, Canada. The 1,598-patient head-to-head study compared Onbrez (indacaterol), a novel long-acting beta-2 agonist, with Spiriva (tiotropium), a long-acting anti-muscarinic. Both medicines are inhaled once-daily to provide bronchodilation, ie increased airflow into the patient's lungs.
Novatis says the data revealed that Onbrez was as effective as Spriva in improving lung function in patients with COPD, while providing greater benefits in terms of reduced breathlessness, lower use of rescue medication and improved health status.
Leonard Dunn, medical director for pulmonology at Clinical Research of West Florida, and lead investigator in the INTENSITY study, said the results "add to the growing body of evidence supporting the use of indacaterol in COPD, delivering sustained improvements in lung function that can translate into real patient benefits". He added that the data confirms Onbrez "is an effective and well-tolerated treatment that should be considered, where available, as a maintenance therapy option for COPD patients".
Onbrez was approved in the European Union in November last year. It was the subject of a complete response letter a month earlier from the US Food and Drug Administration but Novatis submitted data from additional studies to the agency in September this year.